Pfizer
Pharma / Biotech
AssociateManager(QualityAssurance–Operations/Compliance/Investigations)
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“Associate Manager (Quality Assurance – Operations/ Compliance/ Investigations) at Pfizer. Skills: Quality Assurance, Quality Compliance, Quality Investigations, cGMP. Review and approve QC documents. Approve batch records”
What You'll Achieve.
inspection readiness; regulatory compliance; cGMP standards
Industry & Context.
Problem-solving; Root cause analysis; Risk assessment
What They're Looking For.
Must Have
B. Pharm/M. Pharm/M. Sc., 4 – 5 years Master’s Degree, 6 – 8 years Bachelor’s Degree, Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations, sterile dosage manufacturing facility, Change Management process, Risk assessments principles and tools, Validation of lab equipment’s, Drug Product Process validations, Regulatory requirements, Compendial Changes, Regulatory Guidelines, Good documentation practices, good manufacturing practices, Site Procedures, corporate polices
Nice to Have
Interpersonal skills, Ability to communicate effectively, Compliance driven approach, knowledge on cGMP and regulations, face national and international inspections
What You'll Do.
Review and approve QC documents
Approve batch records
Approve validation protocols
Approve validation reports
Review and approve SOPs
Approve specifications
Approve study protocols
Review stability reports
Ensure manufacturing quality compliance
Ensure adherence to procedures
Participate in Site Change Review Committee
Assess critical changes
Provide quality oversight
Ensure implementation of Quality Management Systems
Ensure effectiveness of Quality Management Systems
Lead audit readiness activities
Lead inspection readiness activities
Interface with regulatory agencies
Ensure compliance with cGMP
Ensure compliance with GDP
Ensure compliance with global regulatory requirements
Drive quality culture improvements
Drive continuous compliance improvements
Review quality system documentation
Approve quality system documentation
Review risk assessments
Approve risk assessments
Lead deviation investigations
Review deviation investigations
Approve deviation investigations
Ensure robust root cause analysis
Ensure effective corrective actions
Ensure effective preventive actions
Drive timely closure of investigations
Escalate critical issues
Utilize advanced investigation tools
Utilize advanced investigation methodologies
Ensure investigation quality meets regulatory expectations
Provide technical guidance
Provide mentoring to junior team members
Coordinate with cross-functional teams
Resolve quality issues
Present critical quality decisions to leadership
Identify process improvement opportunities
Drive efficiency initiatives
Ensure timely closure of action items
Ensure timely closure of commitments
Report critical non-compliance issues
Escalate critical non-compliance issues
How You'll Work.
Team & Collaboration
Cross-functional teams; Cross-functional relationships
Communication Scope
Communicates effectively
Process & Methodology
Change Management
Full Job Description
**Use Your Power for Purpose** Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, leads investigations, and collaborates with cross-functional teams to maintain cGMP standards and inspection readiness. **What You Will Achieve** Role Responsibilities: * Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities) * Advanced technical document review and approval capability * Expertise in change control and risk assessment * Strong knowledge of chemical and microbiological testing * Knowledge of investigations tools and root cause analysis methodologies * Understanding of manufacturing operations, engineering, and validation systems * Experience in handling regulatory inspections * Accountability: Self-driven, proactive, and responsible for quality outcomes * Critical thinking and strong compliance mindset * Strong time management and problem-solving abilities * Interpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels * Decision Making: Makes timely, independent, and risk-based quality decisions * Leadership Skills: Provides guidance, coaching, and technical direction to team members Core Responsibilities: **Quality Operations** * Review and approve QC documents (BQ, CQ), batch records, validation protocols, and reports * Review and approve SOPs, specifications, STPs, and study protocols * Review stability reports, APRs, and trend reports * Ensure manufacturing quality compliance and adherence to procedures * Participate in Site Change Review Committee (SCRC) and assess critical changes * Provide quality oversight for manufacturing and laboratory operations **Quality Compliance** * Ensure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations) * Lead audi
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