Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Regulatory & Technical Expertise
Timeline
Generic

Zahid Muhammad

Quakertown,PA

Summary

Global Quality leader with 30+ years of experience in pharmaceutical and biologics manufacturing environments, leading Quality Assurance and Validation programs supporting clinical and commercial operations. Extensive expertise in facility, utilities, equipment, computer system, and process validation within sterile GMP environments. Proven track record of building high-performing QA organizations, leading global validation initiatives, driving inspection readiness, and ensuring compliance with FDA, EU, and ICH regulatory requirements. Experienced in partnering with Manufacturing, Engineering, Technical Development, and Supply Chain teams to deliver compliant, efficient, and scalable manufacturing capabilities. Recognized for strengthening quality systems, leading regulatory inspections, and enabling successful product launches across global pharmaceutical organizations.

Overview

35
35
years of professional experience
1
1
Certification

Work History

Director, Quality Assurance – Facilities, Utilities, Equipment, Automation & Data Integrity

Merck
West Point, PA
01.2020 - Current
  • Provide executive Quality oversight for validation and qualification programs supporting biologics development and manufacturing operations across complex GMP facilities.
  • Provide QA leadership for validation of facilities, utilities, equipment, cleaning, and thermal systems supporting sterile and biologics manufacturing operations.
  • Lead Quality oversight for validation lifecycle activities including URS, IQ, OQ, PQ, and continued process verification for new laboratories and manufacturing infrastructure.
  • Serve as Quality Lead and single point of contact for the Modality Agnostic Chemistry Scale Up Center supporting facility design and operational readiness from concept through build and operational deployment.
  • Partner with Engineering, Automation, and Manufacturing organizations to ensure compliant qualification and validation of complex GMP manufacturing systems.
  • Provide technical leadership on Data Integrity initiatives across manufacturing, laboratories, and clinical packaging operations.
  • Support pipeline development programs and commercial manufacturing operations through troubleshooting, technical problem solving, and validation oversight.
  • Ensure compliance with global GMP regulations and regulatory expectations for biologics and sterile manufacturing environments.
  • Key Contributions

Director, Computer System Validation, Quality Systems & Compliance

Merck
West Point, PA
01.2018 - 01.2020
  • Directed enterprise-level Data Integrity and Computer System Validation initiatives supporting laboratory and manufacturing systems across multiple global sites.
  • Established global Data Integrity remediation strategy for laboratory and manufacturing computerized systems.
  • Developed validation master strategies and remediation plans for both PC-based and non-PC systems.
  • Led cross-functional teams responsible for validation and compliance remediation across multiple manufacturing sites.
  • Directed inspection readiness initiatives ensuring compliance with regulatory expectations and corporate data integrity standards.
  • Implemented quality system enhancements including new policies, procedures, and training programs supporting validation governance.
  • Key Contributions

Director, Quality Assurance & Regulatory Affairs

Amring Pharmaceuticals
Berwyn, PA
01.2015 - 01.2018
  • Led site Quality operations supporting development and commercialization of pharmaceutical products including sterile and oral dosage forms.
  • Directed QA operations including investigations, deviations, CAPA, change control, product complaints, and supplier quality programs.
  • Implemented a comprehensive GMP Quality Management System supporting both US and EU regulatory expectations.
  • Supported new product development programs including process scale-up, validation, and regulatory submission activities.
  • Led inspection readiness initiatives and regulatory interactions for commercial product approvals.
  • Provided technical QA guidance for validation protocols, process development, and manufacturing optimization activities.
  • Key Contributions

Director, Quality Assurance Operations & Compliance

Pharmaceutics International (Pii)
Towson, MD
01.2014 - 01.2015
  • Oversaw QA operations supporting contract manufacturing of sterile and oral pharmaceutical products.
  • Directed QA oversight of GMP manufacturing operations supporting clinical and commercial production.
  • Led vendor and supplier qualification audits across US and international partners.
  • Managed QA teams responsible for batch review, investigations, and compliance activities.
  • Served as Quality Lead during regulatory inspections and compliance audits.
  • Key Contributions

Manager, Quality Assurance – Contract Manufacturing & Supply Chain

ThromboGenics
Iselin, NJ
01.2013 - 01.2014
  • Provided quality oversight for CMOs, CTLs, and logistics partners supporting commercial biologics manufacturing.
  • Managed investigations, CAPA, change controls, and regulatory inspection readiness activities.

Manager, Quality Assurance – Commercial Manufacturing

Endo Pharmaceuticals (Auxilium)
Malvern, PA
01.2010 - 01.2013
  • Oversaw quality agreements and compliance performance for global CMOs and internal manufacturing operations.
  • Led remediation programs supporting regulatory approvals and commercial product launches.

Manager, Quality Assurance – Biotechnology

Pfizer Inc.
New York, NY
01.2007 - 01.2010
  • Managed investigations, CAPA programs, and product quality complaint systems supporting biologics and vaccine manufacturing.
  • Approved batch records and manufacturing documentation supporting commercial product release.

Quality Assurance Team Leader / Quality Control Laboratory Team Leader

Pfizer Inc.
01.1991 - 01.2006
  • Progressively responsible leadership roles supporting pharmaceutical manufacturing operations.
  • Led laboratory and QA teams responsible for analytical testing, investigations, and GMP compliance.
  • Supported validation programs for manufacturing processes and computerized systems.
  • Mentored quality professionals and improved operational efficiency across laboratory operations.
  • Earlier Career

Education

Master of Business Administration -

New York Institute of Technology

Master of Science - Chemistry

City University of New York

Master of Science - Industrial Chemistry

University of Karachi

Skills

  • Global Quality Assurance Leadership
  • Validation Lifecycle Management (URS, IQ, OQ, PQ, CPV)
  • Facilities, Utilities & Equipment Qualification
  • Process & Cleaning Validation
  • Computer System Validation (CSV) & Data Integrity
  • Sterile & Aseptic Manufacturing Environments
  • GMP Compliance (FDA, EU, ICH)
  • Investigations, Deviations & CAPA Strategy
  • Inspection Readiness & Regulatory Audits
  • Global Quality Systems & Compliance Governance
  • Cross-Functional & Multi-Site Leadership
  • Vendor & CMO Quality Oversight

Accomplishments

  • Regulatory Inspection Leadership: Successfully led and supported multiple FDA regulatory inspections including Pre-Approval Inspections (PAI) and GMP inspections with strong compliance outcomes and minimal observations.
  • Global Data Integrity Transformation: Directed enterprise-wide Data Integrity remediation strategy across laboratory and manufacturing systems, establishing governance, prioritization frameworks, and validation remediation programs across multiple Merck manufacturing sites.
  • Facility & Manufacturing Readiness Leadership: Served as Quality Lead for major capital expansion programs supporting biologics and chemistry scale-up facilities, ensuring GMP-compliant design, qualification, and operational readiness from concept through build and deployment.
  • Quality System Transformation: Designed and implemented a comprehensive Quality Management System within two months at Amring Pharmaceuticals, enabling rapid commercialization and regulatory readiness for multiple product launches.
  • Product Launch & Regulatory Success: Supported the successful launch of multiple pharmaceutical products and ANDA submissions, contributing to significant commercial growth and accelerated market entry.
  • Global CMO & Supply Chain Quality Oversight: Established supplier qualification programs and performed extensive global GMP audits to strengthen supply chain compliance and vendor quality performance.
  • High-Performance Team Development: Built and led high-performing Quality and Validation teams, mentoring technical professionals and leaders while strengthening organizational capabilities across Quality Assurance, Compliance, and Validation functions.

Certification

Certified by the Parenteral Drug Association (PDA) in the manufacturing of parenteral drugs

Regulatory & Technical Expertise

  • FDA GMP (21 CFR 210/211)
  • Validation Lifecycle Management
  • Computer System Validation & Data Integrity
  • Sterile Manufacturing Compliance
  • Global Regulatory Inspections
  • Quality Management Systems (QMS)
  • Process Excellence & Continuous Improvement

Timeline

Director, Quality Assurance – Facilities, Utilities, Equipment, Automation & Data Integrity

Merck
01.2020 - Current

Director, Computer System Validation, Quality Systems & Compliance

Merck
01.2018 - 01.2020

Director, Quality Assurance & Regulatory Affairs

Amring Pharmaceuticals
01.2015 - 01.2018

Director, Quality Assurance Operations & Compliance

Pharmaceutics International (Pii)
01.2014 - 01.2015

Manager, Quality Assurance – Contract Manufacturing & Supply Chain

ThromboGenics
01.2013 - 01.2014

Manager, Quality Assurance – Commercial Manufacturing

Endo Pharmaceuticals (Auxilium)
01.2010 - 01.2013

Manager, Quality Assurance – Biotechnology

Pfizer Inc.
01.2007 - 01.2010

Quality Assurance Team Leader / Quality Control Laboratory Team Leader

Pfizer Inc.
01.1991 - 01.2006

Master of Science - Chemistry

City University of New York

Master of Science - Industrial Chemistry

University of Karachi

Master of Business Administration -

New York Institute of Technology
Zahid Muhammad