Manager - External Supply Operation Quality

Pfizer; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

Pfizer seeks a senior Quality Assurance/ESOQ expert to manage quality and compliance for external CMOs and suppliers, ensuring GMP/GDP adherence and on-time delivery of high-quality products. You will assess supplier materials, support audits, and lead risk mitigation with cross-functional teams.

The role requires extensive experience in pharma manufacturing, strong regulatory knowledge, and proven ability to influence decisions and drive quality improvements globally.

Qualifications

• Bachelor of Science minimum in a technical field; pharmacy/engineering preferred.
• 10 years in pharma with 5+ years sterile experience in Production or QA.
• Experience with external suppliers and contract manufacturers; GMP/GDP knowledge.

Responsibilities

• Oversee quality/compliance for external CMOs and suppliers per procedures.
• Assess supplier products, processes, and documents to meet specs.
• Support audits and regulatory inspections; conduct compliance assessments.
• Lead vendor risk programs and quality improvement actions.
• Onboard new CMOs and support product launches; offboard activities.
• Review APR, PQR, stability reports and endorse batch disposition.
• Provide Quality Leadership within VSOT and develop quality agreements.

Skills

Supplier management

Leadership in virtual teams

Regulatory knowledge

Quality decision making

Technical writing

Communication skills

Education

Bachelor of Science degree (minimum)

Pharmacy, Engineering, or related discipline

Tools

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.

• 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.
• 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 escalat 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 to 20% 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 on Pfizer Careers.

Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.