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Michael Abraham

Director, Global Quality & Compliance

Sr. Director of Global Clinical Quality Assurance and PV (Pharmacovigilance)

Hayward, California

Section title

Michael Abraham's Email Addresses & Phone Numbers

Michael Abraham's Work Experience

Pfizer

Director, Global Quality & Compliance

April 2016 to June 2017

525 Market Street, San Francisco, CA 94105

Medivation

Director, Global Quality & Compliance (Head of Commercial QA)

April 2016 to August 2016

525 Market Street, San Francisco, CA 94105

Astex Pharmaceuticals Inc, An Otsuka Company..

Senior Director Global Quality Assurance-"GxP"

April 2014 to April 2016

4140 Dublin Blvd, Dublin CA 94568

Michael Abraham's Education

Temple University

Master of Science - MS, Quality Assurance and Regulatory Affairs

2019 to 2021

San Jose State University

Bachelor of Science (BS), Industrial Technology, Quality Assurance, and Computer Electronics Minor-Business

1988 to 1992

About Michael Abraham's Current Company

Pfizer

Prepare and lead, PAI inspection strategies for Pfizer Oncology; in-house, CMOs and contract laboratories (CTLs). Responsible for Inspection mgmt. Established Commercial QA systems,Oversee process validation of DS(API), Drug Product, Packaging & labeling and Technology Transfer. Author, negotiate the Quality agreements between CROs,CTLs, CMOs and Precision Medicine devices. Qualify CMOs/CROs.Review and approve QA qtr performance metrics (QA-MGMT review)....

About Michael Abraham

đź“– Summary

Director, Global Quality & Compliance @ Pfizer Prepare and lead, PAI inspection strategies for Pfizer Oncology; in-house, CMOs and contract laboratories (CTLs). Responsible for Inspection mgmt. Established Commercial QA systems,Oversee process validation of DS(API), Drug Product, Packaging & labeling and Technology Transfer. Author, negotiate the Quality agreements between CROs,CTLs, CMOs and Precision Medicine devices. Qualify CMOs/CROs.Review and approve QA qtr performance metrics (QA-MGMT review). Review MSA's between CMOs/CTLs/CROs. Establish commercial, Inspection, complaint, Risk Mgmt QA systems.Establish Quality Metrics system. Lead QA leader for Global filing team.Participate in special compliance projects. Manage activities of internal employees and CMO for Drug Product Dispositions, validation( PV-solid dosage, Packaging & labeling, purification processes).• Coordinate work between purification/downstream development group.Review and Approve Regulatory submission Docs eCTD (Module 3 & 4). From April 2016 to June 2017 (1 year 3 months) 525 Market Street, San Francisco, CA 94105Director, Global Quality & Compliance (Head of Commercial QA) @ Medivation Prepare and lead, pre-approval inspection strategies for Medivation; in-house, CMOs and contract laboratories (CTLs)..Responsible for establishing of Commercial QA systems, Oversee process validation of DS(API), Drug product, Packaging & labeling,Technology Transfer, scale-up. Author, Quality agreement between CMOs, CTLs, CROs. Established QTA, Risk Mgmt, Data integrity policy, complaint Mgmt, PIP program, Inspection Mgmt. Led, review and approve QA-GxP quarterly performance metrics (Quality Mgmt Review). Review eCTD Modules 3&4.Establish Quality Metrics system.• Manage activities of internal employees and CMO for, Drug Product dispositions, Validations (PV -API, Solid dosages Packaging & labeling, purification processes)•Coordinate work between purification/downstream development group. Principal QA leader for Global filing team. Directed special compliance projects. From April 2016 to August 2016 (5 months) 525 Market Street, San Francisco, CA 94105Senior Director Global Quality Assurance-"GxP" @ Astex Pharmaceuticals Inc, An Otsuka Company.. • Establishment and maintain quality assurance systems in compliance with global requirements to support drug development •Provide leadership & oversight to the QA departments responsible: Quality systems, Audit Prog mgmt, Inspection mgmt, Product Disposition, QP release, Quality metrics, Annual Product, Complaints & Management reviews .Provide Quality strategies for 1,3, and 5years to Sr, Mgmt Authored, coordinated, negotiated & maintained: QA agreements, Clinical Quality plans, eTMF plans, CROs/CSPs ,GCLP, CMOs & QPsReview Clinical Protocols, Clinical Study Rpts, CRFs, Consent Forms-ICFs, & TMF, SMPs, SAPs, IBs, unblinding mgmt & Randomization plans & DSURs, safety reportsReported critical clinical quality deficiencies to Sr. Mgmt. in a timely manner and initiate/closure CAPAs, Sites enrollments hold & site closuresEstablishment of the quality systems: GCP, GLP & GMP, ICH E6 R1 Vs. R2, EU Dir 536/2014•Prep. of Clinical sites, CROs, In-house, & CMO for Regulatory/HA Inspections•Qualified: CRO’s/, Clinical E-system vend, GCLP labs & (PK/PD)•Monitor/Oversee Serious GCP breaches at Clinical sites•Direct computer validation activities-Astex (Clinical-Ops- CTMS, eTMF, EDC & Safety)•Ensured Inspection ready all times.Internal audits: Pharm-Ops, Clin-Ops, Data mgmt, Safety-PV, & TMF/eTMF •Manage & led annual audits & CMOs, CROs, CTLs, GCLP, DMPK labs, IT vendors•Review and approval of INDs, IMPDs, CTAs, NDA, MAA, and supplements•Review CMC/QA of Annual Reports (INDs & IMPDs ) and Annual Product Reviews•Established complaint Mgmt, Risk mgmt(ICH Q9), Mgmt Review, & QA PV system•Direct in setting up of Astex’s computer system & IT Infrastructure validation/qual/part 11 compliant• QA rep-Astex, for Collaboration studies, acquisitions & due diligence's•Participates in global Otsuka forums to set Quality Assurance policy and strategy.•Manage audit programs for Pharmaceutical QA "GxP"(GCP, GLP, GMP &GLP) From April 2014 to April 2016 (2 years 1 month) 4140 Dublin Blvd, Dublin CA 94568Associate Director, Quality Assurance -"GxP" @ Astex Pharmaceuticals Inc, An Otsuka Company.. • Establishment & maintain quality assurance system in compliance with global requirements to support various phases of drug development •Provide leadership and managerial oversight to the Quality departments responsible for Quality systems, Audit programs (GCP, GLP & GMP), Inspection Mgmt, Quality metrics, APR and Mgmt reviews •Authored, negotiated & maintained: QA agreements W/- CROs, Distri,CMO, CTLs Review Protocols, Clinical Study reports(CSRs),IBs ,CRFs, ICFs, DSURs, & ICRSs Report critical GCP pract. deficiencies to Sr./QA mgmt. in a timely manner and initiate/closure CAPAs, Sites enrollments hold & site closures Formulate "GxP"QA strategy for audits and Quality plans•Direct the upgrade of the quality systems at CMOs/CROs (API & Drug Product)•Preparation of clinical sites, CROs, & CMO for Global REG. Inspections•Qualifications all: CROs, GCLP/ Central labs, API / DP CMOs, •Managed QP-EU releases of all Phases IMPs•Established computer validation activities at Astex (QA & Clinical-OPs systems)•Approved of valid-protocols & reports (utilities, BOD, analytical, process equip& process validation), unplanned deviations, investigation, OOS reports, MBRs, and stability protocols)•Ensured operations at Astex’s are compliant with global regulations, & inspection ready.•Managed annual audits programs: Clinical sites, CROs, CTLs & GCLP/Pk/PD lab, Clin-Vend, E-systems•Responsible In-house-facility, Lab instruments, Process equipment-Qual, PMs & Calibration•Review and approval of INDs, IMPDs, CTA, supplements, & eCTD module 3,4 & 5•Review QA sections of Annual Reports (INDs & IMPDs ) & Annual Product Reviews• Appraised- CMC, NDAs, CBEs & APRs•Established Astex’s comp. Valid-systems & IT Infrastructure valid/qualification• Key QA of Astex, for Collaboration studies & due diligence audits•Principal mem. Global Otsuka forums to set QA (GxP) policy and strategy. From September 2011 to April 2014 (2 years 8 months) 4140 Dublin Blvd , Dublin CA 94568Associate Dir. QA/ GxP compliance/Validation @ Supergen, Inc • Establishment and maintain quality assurance system in compliance with global requirements to support various phases of drug development - preclinical to potential commercial •Provide leadership and managerial oversight to the Quality departments responsible for Quality systems, Quality metrics, Audit programs, Annual Product, and Management review .Review Clin Protocols, Clin.study reports, CRFs,ICFs, IBs and Safety reports(CIOMS,DSURs & aggregate reports)•Author, coordinated, negotiate & maintain Quality agreements between SUPG and CMOs/CROs, Dist. &Labs•Direct establishment of the quality systems at CMOs/CROs (API & Drug Product)•Preparation of CMOs, and clinical sites for Global Regulatory Inspections•Qualifications of all: API / drug product, labs / CRO’s, RSM, and critical raw material CMOs. Responsible for Final disposition of all CTMs/IMPs/Products•Manage QP ( EU-Qualified Person) releases of all Phases IMPs•Direct computer related validation activities at Astex (QA & Clinical operations)•Approval of validation protocols & reports (facility utilities, BOD, analytical, process equipment & process validation), planned / unplanned deviations, investigation reports, OOS reports, master batch records, and stability protocols)•Ensures operations at SUPG’s are compliant with applicable global regs and SUPG always prepared for HAs and corp. audits. •Manage & Performed annual audits Clin. sites,CMOs, CROs,CTLs & Bio-analytical Labs•Quality expertise for scale-up, tech transfer, and Process validation•Review and approval of INDs, IMPDs, CTA, NDAs, MAAs & supplements•Review QA sections of Annual Reports (INDs & IMPDs ) and APRs•Technical expertise to Reg. Affairs on CMC, NDAs, CBE (changes being effected) & APRs•Direct in setting up of SUPG’s computer Val sys & IT Infrastructure validation/qualification• Key QA rep. of SUPG, for Collaboration studies due diligence•Manage audit programs for Pharma QA-GMP, clinical and Pre-clinical sciences From November 2006 to September 2011 (4 years 11 months) 4420 Dublin Blvd , Dublin CA 94569Sr. Mgr QA & Regulatory Compliance- GxP @ Supergen, Inc • Establishment and maintain quality assurance system in compliance with global requirements •Provided leadership and managerial oversight to the Quality responsible for Quality systems, Audit programs (Clinical, GMP & GLP), Inspection mgmt, Product Disposition, Annual Product & Management review.Report significant clinical quality deficiencies to Sr./QA mgmt. in a timely manner and initiate/closure CAPAs, Sites enrollments hold & site closuresReviewed Clinical Protocols, Clinical Study Rpts, CRFs, Consent Forms-ICFs, & TMF, SMPs, SAPs, IBs, Blinded, Randomization plans & DSURs, ICSR, safety reports. •Authored, coordinated, negotiate & maintain QA agreements W-SUPG and CRO/CMOs/CTLs, PKg, Dist.•Establish, oversee, & manage SOPs for global Quality (Pre-clinical, clinical QA, & GMP)•Review of Downstream processing docs, Bioreactors, and UF/DF process qualification•Qualifications of all: Clinical computer system vendors/API / D-Product, labs / CRO’s, Pkg & Dist, RSM,•Direct computer related validation activities at SUPG (QA & Clinical operations)•Approved validation protocols & reports (facility utilities, BOD, analytical, process equipment & process validation), unplanned deviations, investigation,, OOS reports, master batch records, and stability protocols)•Ensured operations at Supergen’s are compliant with applicable global regulations & SUPG always inspection ready•Conducted US & Ex US Quality System audits (CMO Qualifications, Assessments, For Cause, &/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH.•Quality expertise for Registration lots and Process validation•Reviewed and approval of INDs, IMPDs, CTA & supplements•Reviewed Annual Reports (INDs, DSURs & IMPDs ) and Annual Product Reviews•Technical expertise to Reg. Affairs on CMC, NDAs, CBEs & Annual Product Reviews•Direct in setting up of SUPG’s computer system & IT Infrastructure validation/qualification From January 2001 to November 2006 (5 years 11 months) Sr. QA Auditor @ Aradigm Corporation • Managed and conducted internal, GMP/GCP audit program and follow-up. Authored procedures for GCP and GMP QA systems• Qualified / audited suppliers, CMO/CRO’s, contract laboratories / manufacturers and follow-up• Principal QA rep. for building an in-house Pilot Fill/Finish plant .• Conducted nonconforming material and laboratory investigations • Reviewed and approved validation protocols (IQ/OQ/PQ: process equipment & utilities)• Reviewed batch records, provided guidance in investigation, track and trend mfg deficiencies• Lead pilot project Integration of Pharmaceutical QA and Device QA systems• Trained junior auditors and compliance technicians• Author and oversee supplier quality agreements and issues• Hosted client and Regulatory bodies audits From March 2000 to January 2001 (11 months) Quality Assurance, Compliance and Education Specialist.III @ BD • Conducted internal audits and follow-up on non-conformances• Performed supplier audits / Gov. subcontract GLP/GCP audits / OEM audits• Hosted/co-hosted FDA, ISO, UL / CSA, corporate, and customer audits• Provided corrective action plan to the regulatory agencies• Reviewed, approved, performed and followed up on corrective actions to assess effectiveness• Represented Quality Assurance on product development team• Wrote Quality plan focused on worldwide compliance for upcoming new products . Participated in design control• Trained groups on various cGMP / audit topics• Performed gap analysis of internal SOPs against QSR and ISO standards• Reviewed QA procedures / SOPs and recommended improvements• Audit of validation studies(facility, systems, and process)• Directed Electronic Signatures / Electronic Records project and represent QA in change control board• Approved DHRs (batch records), Manufacturing support docs, protocols and variances • Author and oversee supplier quality agreements and issues• Participated on process improvement team –CAPA From February 1999 to March 2000 (1 year 2 months) Genentech, South San Francisco Supervisor, Quality Assurance MQA / QACD group @ Genentech •Supervised 6-13 MQA reviewers / associates (QA Inspections and Batch Record reviews group)•Represented Quality Assurance at operational and cross-functional group meetings• Provide guidance to the Downstream Process Development group to be effective and efficient in a fast-paced environment.•Review Batch records, investigations/deviations and provide QA guidance in closing of investigation •Approved Master batch records, Master label, Qualification protocols, deviations, and incident reports•Harmonized resources and department operations to meet project deadlines and lot release timelines•Coordinated resolution of production/Inspection issues and assisted with technical troubleshooting•Performed internal audits ,Review inspection trends and followed up on corrective actions•Participated in Process validation, Equipment Qualification & Computer system validation,•Qualified / audited suppliers, CRO’s, contract laboratories / manufacturers and follow-up•Provide cGMP, OJT training to MQAs and other related departments associates•Co-hosted audits of FDA/EU (PAI & Routine- provide escort of Fill, Finish and Inspection areas)•Managed reserve file area: audits, inspection reports, software optimization, and investigations•Managed returned drug product and damaged returned drug products•Supervised technical staff including setting objectives and development plans, performance management, career development, training, mentoring, and guiding From September 1997 to October 1998 (1 year 2 months) South San FranciscoQA Associate,III @ ALZA Corporation •Supported product registration activities: IND, NDA, CMC, and international filings•Prepared specifications for raw materials, intermediates, and finished products•Presented specifications to Material Specification Review Board•Optimized SOP’s and forms to streamline clinical production•Submitted proposal for quotes of controlled substances to DEA•Maintained and controlled raw materials (Controlled substances-Class-II)•Coordinated and monitored testing of materials at all stages of production•Prepared clinical batch records and stability protocols for various studies•Audited batch records and resolved issues encountered in audit•Predicted and tracked raw materials (CTM) for clinical and experimental production•Conducted investigations for deviations, customer complaints, and client requests•Co-hosted audits of FDA (PAI & Routine), MHRA, BfarM, TGA and clients•Author and oversee quality agreements and resolved issues related to Nicoderm™and Duragesic™•Participated in internal GMP audits•Audited complete batch records and authorized release of intermediates and finished product•Approved change control documents and validation / qualification protocols•Coordinated QA functions in successful launching of Rx to OTC •Lead routine project improvement teams ( MFG-Pro, AMY-EDMS, Real time review of batch record)•Assisted clinical production in the review of batch records, specifications, and stability protocols•Directed activities of in-process auditors From April 1994 to September 1997 (3 years 6 months) Sr. Director, Global Clinical Quality Assurance and Pharmacovigilance @ Quark Pharmaceuticals Manage all audit (GxP) programsEstablish & implement Clinical QA Mgmt System (CQMS), for GCP QA in compliance W/global Req.Ensure clinical trials performed per study protocols & compliance with cGCP and ICH guidelinesCOVID19-Co-Author- remote monitoring, rSDV & ICF -guidelines Appraise safety reports, Safety Mgmt plans, SAE Recon plan, PDs, & site CAPAsIdentify & Prep Investigator sites,-inhouse FDA-BIMO,Health Canada, EMA, HSA, BfArM & TGAs audits.Conduct reviews of Clinical Protocols, CSRs, IBs, eCRF/CRF, ICFs, Monitoring plan Safety Mgmt plan, SAP plan, Blind maint Plan & Data mgmt plan.Author QA Agreement with CROs,Clin-Quality plan, eTMF plan, Insp. Readiness Roadmap-GlobalDevelop & ensure timely execution of cGCP & GLP Audit PlanManage & audits of, inhouse Clinical systems (SaaS)Performed audits of e-TMF CROs-risk-based ( My trial,Veeva Vault & Trial interactive-eTMF)Conduct GCP audits-Investigator sites, CROs,& Central labs vendors(IWRS, ERT, ePRO), & Datacenters Oversee PV/Drug safety audits, KPIs, metrics &DSMBProvide GCP guidance to Clinical Ops,DM & PV based on analysis & interpretation of updates to GCP regulations -assure best industry practicesPerform review-policies, SOPs, WI, study protocols, Reg. submissions, PDs, deviations, CAPAs & other essential documents (ICH-E6-R2)Monitor CAPAs defined to address GCP issues by working with PIs/QIs, CROs & in-houseConduct cGCP training for clinical dept, clinical site staffs, & investigators meeting.Report significant GCP deficiencies to Sr./QA mgmt in timely manner and initiate/closure CAPAs, Sites hold enrollments & Site closures Thoroughly acquainted W/ Cell & Gene Therapy (CT & GT) ICF requirements, IBC & IRB review & Nonclinical evaluations.Responsible for prep, coordination, and mgmt of Reg. agency inspections (Health Canada, HSA, EMA & FDA) including sponsor inspections & investigator site inspectionsManaged consultants, contractor and hiring of Associates & Budgets, Newark, CADirector Global Clinical Quality Assurance @ Zogenix, Inc. Establish and implement a Clinical Quality Management System (CQMS), for GCP QA in compliance with applicable regulatory requirements (US and ROW)Ensure clinical trials are performed by study protocols and in compliance with cGCP and ICH guidelinesAppraise safety reports, PV investigations, first clinical drug shipments, PDs, Investigations, & CAPAsIdentify and Prep Investigator sites for FDA and EMA audits.Conduct reviews of CSRs, IBs, Clinical Protocols, CRFs, ICFs, SMPs, SAP, Randomization plans Author Quality Agreement between Zogenix and CROsDeveloped and ensured timely execution of the cGCP Audit Plan for PAI inspectionManage and participate in audits, internal process, external vendors & clinical investigator sites; determine compliance status and identify compliance risks Performed audits e-TMF at CROs (Veeva Vault & Trial interactive-eTMF-TransPerfect) Conducted PAI readiness Investigator sites audits, CROs facilities, and vendors(IWRS, ERT, ePRO),Central labs, ECHO vendor by the Audit PlanProvide cGCP QA guidance to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best industry practicesPerform detailed review of policies, SOPs, WI, clinical protocols, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.Monitor and reinforce timely completion of GCP CAPAs for sites and in-houseConduct cGCP training for clinical team members, investigators, clinical site staff, and at investigator meeting as requiredReport significant clinical quality deficiencies to Sr./QA mgmt in a timely mannerResponsible for preparation, coordination, and management of regulatory agency inspections, including sponsor Clin-vendor inspections and clinical investigator site Determines the need for consultants, hiring, and managing of consultants From May 2018 to September 2018 (5 months) Emeryville, CaliforniaAssociate Director, Quality Assurance -"GxP" @ Astex Pharmaceuticals Inc, An Otsuka Company.. • Establishment and maintain quality assurance system in compliance with global requirements to support various phases of drug development•Provide leadership and managerial oversight to the Quality departments responsible for Quality systems, Quality metrics, Audit programs, Annual Product & Management review •Author, coordinated, negotiate & maintain Quality agreements between Astex and CMOs/CROs, Dist. &LabsReview IBs, protocols. CRFs, CSRs, ICFs, TMF, SMP, Blinded study mgmt, SAP, PDs, Randomization- plans, •Direct the establishment of the quality systems at CMOs/CROs (API & Drug Product)•Prep. of CMOs, and clinical sites for HA/ Regulatory Inspections•Qualifications of all: API / drug product, labs / CRO’s, RSM, and key Intermediate CMOs•Manage QP-EU releases of all Phases IMPs•Direct computer related validation activities at Astex (QA, IT Infrastructure & Clinical-Ops E-systems)•Approval of validation protocols & reports (facility utilities, BOD, analytical, Equipment & process validation), unplanned deviations, investigation reports, OOS reports, master batch records, and stability protocols)•Ensures operations at Astex’s are compliant with applicable global regulations & Astex is always prepared for regulatory inspections and corporate audits. •Manage audit programs and CMOs, CROs, GCLP Labs, Bio-analytical audits•Responsible final Disposition of CTM/IMP/Product to Clinics•Review and approval of INDs, IMPDs, CTA ,NDA ,MAAs and supplements•Review QA sections of Annual Reports (INDs & IMPDs ) and Annual Product Reviews•Technical expertise to Reg. Affairs on CMC, NDAs, CBE (changes being effected) & APRs•Direct in setting up of Astex’s computer systems & IT Infrastructure validation/qualification• QA . of Astex, for Acquisitions, Collaboration studies & due diligence'sQA approval of non-clinical protocols and reports for toxicology studies in rats, dose ranging, and efficacy studies in rabbits and non-human primates. From September 2011 to October 2013 (2 years 2 months) 4140 Dublin Blvd Suite #200


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Michael Abraham works for Pfizer


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Michael Abraham is Director, Global Quality & Compliance


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Michael Abraham's personal email address is m****[email protected]


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Michael Abraham's phone (213) ***-*123


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Michael Abraham works in the Pharmaceuticals industry.


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Michael Abraham's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

2 year(s), 2 month(s)

Michael Abraham's Willingness to Change Jobs

Unlikely

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