Associate Manager-Manufacturing Compliance

Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

In this role, you will:

• Responsible for implementing and maintaining the quality systems and ensuring compliance throughout end-to-end manufacturing operations

• Responsible for inspection readiness activities and ensuring all the manufacturing processes are in compliant with Pfizer policies and regulatory guidelines

• Prepare and maintain Quality Risk Assessments for equipment and processes.

• Track implementation of mitigation plans and ensure timely closure of identified risks.

• Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, scale-up, exhibit, intended, and process validation batches.

• Ensure all documentation complies with GDP and ALCOA principles.

• Initiate Change Control Forms (CCFs), coordinate with cross-functional teams for impact assessment, and manage pre-approval and closure.

• Update procedures as per approved CCFs and ensure timely upload in PLS.

• Monitor and track action items related to CCFs for closure within defined timelines.

• Prepare responses to audit observations and propose CAPAs in consultation with SMEs, owners, and QA.

• Track CAPA implementation and provide regular updates to stakeholders.

• Support investigations and ensure timely closure of CAPAs and commitments.

• Review and approve SOPs, job aids, and SOJTs in PDOCS as primary or secondary owner.

• Prepare, review, and execute protocols and user requirement specifications.

• Manage classified area access for colleagues, contingent workers, and service providers.

• Review and approve alarm reports, conductivity reports, NVPC trend reports, and APQR reports.

• Verify NVPC monitoring activities and perform assessments of PQS, CAS, and compendial requirements.

• Establish alert and action levels for Environmental Monitoring.

• Prepare, review, and approve cross-contamination strategy documents and PCER documents.

• Deliver Instructor-Led Training (ILT) sessions to colleagues and service providers as required.

• Participate in regulatory and RQA audits and ensure compliance with applicable standards.

• Ensure document management and walkthrough compliance.

• Maintain adherence to GDP and ALCOA principles in all documentation and processes.

Here Is What You Need (Minimum Requirements)

• Master’s degree/bachelor's degree in pharmacy with 6+ years of experience preferably in Manufacturing or Quality Assurance department in a sterile Injectable manufacturing site.

• Must have extensive exposure to manufacturing operations, IPQA activities, QMS activities and inspection readiness

• Strong understanding of USFDA regulatory requirements and compliance standards.

• Excellent attention to detail and organizational skills.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Effective written and verbal communication skills.

• Skills with Lean six sigma tools

Bonus Points If You Have:

• Demonstrated working knowledge and understanding of sterile injectable manufacturing procedures and processes

• Knowledge of Good Manufacturing Practices {also cGMP}, validation, audit techniques, and working knowledge of statistics

• Experience with audit processes and corrective action plans.

• Strong problem-solving skills.

• Knowledge of drug product requirements

Work Location Assignment: On Premise

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

Quality Assurance and Control