Manager - External Supply Operation Quality

Pfizer Pte Ltd; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Pfizer Pte Ltd in Singapore seeks a senior Quality Assurance & Compliance professional to ensure external manufacturers and suppliers deliver high-quality products on time and compliant with GMP/GDP regulations. You will lead QA activities across the ESOQ Tier 2 structure and influence decisions with global teams.

Qualified candidates will have a BS degree, 10+ years in pharma with sterile experience, and strong collaboration, communication, and problem-solving skills.

Qualifications

• Bachelor of Science degree (minimum) in a technical discipline.
• 10 years' experience in the pharmaceutical industry with 5+ years in sterile production/QA.
• Experience in API/DS and Drug Product manufacturing.

Responsibilities

• Oversee quality/compliance for external CMOs and suppliers.
• Assess supplier products, processes and documentation to ensure specs.
• Support audits and regulatory inspections related to ESOQ activities.
• Lead risk assessments and quality improvement initiatives.
• Manage vendor risk and quality agreements.
• Support onboarding of CMOs and product launches.
• Endorse batch disposition and review APR/PQR/stability reports.

Skills

Experience with external suppliers/CMO

Quality leadership in virtual teams

Advanced computer skills (MS Office, Q

SAP

QTS

Veeva Vault

Technical writing

Verbal and written communication

Presentation skills

Problem-solving and innovation

Leadership in cross-functional intiati

Managing quality/compliance activities

Influence and collaboration

Education

Bachelor of Science (minimum), Pharmacy/Engineering or related technical discipline

Tools

MS Office

SAP

QTS

Veeva Vault

Job description

ROLE DESCRIPTION

· Role and Accountabilities

Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer's network of external suppliers, CMOs, and partners are supported to deliver high quality products, on time, and in compliance with all established standards, agency guidelines, and applicable GMP/GDP regulations.

• Responsibilities
• Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/products to Pfizer according to established procedures.
• Assess the quality of external suppliers' products, processes, and related documents while ensuring product specifications are met and quality systems are maintained.
• Support internal and external partners with auditing activities related to ESOQ activities or contractor portfolios (RQA audits or regulatory inspections).
• Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence.
• Manage vendor risk, implementing Quality Improvement Plans and supporting Risk Assessments, QRTs and QANs.
• Support onboarding of new CMOs and product launches.
• Support offboarding activities for exiting CMOs, products, and SKUs.
• Make product quality decisions leveraging quality and manufacturing expertise while ensuring compliance with regulatory and Pfizer requirements.
• Influence quality decision making in line with industry and Pfizer requirements.
• Provide Quality Leadership within Virtual Site Operating Teams (VSOT).
• Partner with colleagues to develop and negotiate Quality Agreements.
• Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), and stability reports.
• Perform batch disposition endorsement.

• Additional Responsibilities
• Identify, develop, and implement continuous improvement initiatives related to ESOQ processes.
• Ensure tracking and documentation of quality-related actions and escalation processes.
• Lead and support investigations, market complaints, risk assessments, and Management Notifications (MN).
• Provide performance metrics and KPI reporting.
• Work independently and handle unusual or complex problems.
• Build and maintain relationships with internal and external stakeholders.
• Support ESOQ leadership as required.

• If applicable
• Manage quality/compliance activities for CMOs, and suppliers.
• Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.

QUALIFICATIONS / SKILLS

• Education
• Bachelor of Science degree (minimum), Pharmacy, Engineering, or related technical discipline.

• Experience
• 10 years' experience in the pharmaceutical industry with minimum 5 years hands‑on sterile experience in Production and/or Quality Assurance.
• Experience in pharmaceutical manufacturing including: API/DS and Drug Product (DP).

• Skills
• Experience with external suppliers/contractors.
• Advanced computer skills in: MS Office, SAP, QTS, Veeva Vault
• Proficient in English and technical writing.
• Strong verbal, written communication, and presentation skills.
• Demonstrated leadership in virtual teams and cross‑functional initiatives.
• Experience managing complex quality and compliance activities.
• Strong problem‑solving and innovation mindset.
• Demonstrated managerial and organizational skills.
• Proactive and persistent.
• Strong planning and organizational capabilities.
• Ability to work independently and appropriately escalated issues.
• Knowledge of US, EU, and global cGxP regulations and inspection trends.
• Proven leadership and facilitation skills.
• Ability to influence and collaborate effectively with peers.

NON-STANDARD WORK SCHEDULE / TRAVEL

• Up to20% travel.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available onPfizer Careers.

Quality Assurance and Control