Associate Manager (Quality Assurance – Operations/ Compliance/ Investigations)

Use Your Power for PurposeResponsible 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 AchieveRole Responsibilities:Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)Advanced technical document review and approval capabilityExpertise in change control and risk assessmentStrong knowledge of chemical and microbiological testingKnowledge of investigations tools and root cause analysis methodologiesUnderstanding of manufacturing operations, engineering, and validation systemsExperience in handling regulatory inspectionsAccountability: Self-driven, proactive, and responsible for quality outcomesCritical thinking and strong compliance mindsetStrong time management and problem-solving abilitiesInterpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levelsDecision Making: Makes timely, independent, and risk-based quality decisionsLeadership Skills: Provides guidance, coaching, and technical direction to team members Core Responsibilities:Quality OperationsReview and approve QC documents (BQ, CQ), batch records, validation protocols, and reportsReview and approve SOPs, specifications, STPs, and study protocolsReview stability reports, APRs, and trend reportsEnsure manufacturing quality compliance and adherence to proceduresParticipate in Site Change Review Committee (SCRC) and assess critical changesProvide quality oversight for manufacturing and laboratory operations Quality ComplianceEnsure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)Lead audit and inspection readiness activities (internal, regulatory, corporate)Interface with regulatory agencies and support inspections (USFDA, MHRA, etc.)Ensure compliance with cGMP, GDP, and global regulatory requirementsDrive quality culture and continuous compliance improvementsReview and approve quality system documentation and risk assessments Quality InvestigationsLead, review, and approve deviation investigations and CAPAEnsure robust root cause analysis and effective corrective/preventive actionsDrive timely closure of investigations and escalation of critical issuesUtilize advanced investigation tools and methodologiesEnsure investigation quality meets regulatory expectations Leadership & General ResponsibilitiesProvide technical guidance and mentoring to junior team membersCoordinate with cross-functional teams for resolution of quality issuesPresent critical quality decisions to leadershipIdentify process improvement opportunities and drive efficiency initiativesEnsure timely closure of action items and commitmentsReport and escalate critical non-compliance issues Here Is What You Need (Minimum Requirements)B. Pharm/M. Pharm/M.Sc.Master’s Degree: 4 – 5 yearsBachelor’s Degree: 6 – 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facilityChange Management processRisk assessments principles and toolsValidation of lab equipment’sDrug Product Process validationsRegulatory requirementsCompendial ChangesKnowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.Adhering to Site Procedures and corporate policesPreferred RequirementsStrong Interpersonal skillsAbility to communicate effectively with all levels within the organization.Compliance driven approach, knowledge on cGMP and regulations.Should face national and international inspections such as USFDA, MHRA, TGA & WHOPfizer 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