This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.\n\nUse Your Power for Purpose\nResponsible 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.\nWhat You Will Achieve\nRole Responsibilities:\nStrong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)\nAdvanced technical document review and approval capability\nExpertise in change control and risk assessment\nStrong knowledge of chemical and microbiological testing\nKnowledge of investigations tools and root cause analysis methodologies\nUnderstanding of manufacturing operations, engineering, and validation systems\nExperience in handling regulatory inspections\nAccountability: Self-driven, proactive, and responsible for quality outcomes\nCritical thinking and strong compliance mindset\nStrong time management and problem-solving abilities\nInterpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels\nDecision Making: Makes timely, independent, and risk-based quality decisions\nLeadership Skills: Provides guidance, coaching, and technical direction to team members\n\nCore Responsibilities:\nQuality Operations\nReview and approve QC documents (BQ, CQ), batch records, validation protocols, and reports\nReview and approve SOPs, specifications, STPs, and study protocols\nReview stability reports, APRs, and trend reports\nEnsure manufacturing quality compliance and adherence to procedures\nParticipate in Site Change Review Committee (SCRC) and assess critical changes\nProvide quality oversight for manufacturing and laboratory operations\n\nQuality Compliance\nEnsure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)\nLead audit and inspection readiness activities (internal, regulatory, corporate)\nInterface with regulatory agencies and support inspections (USFDA, MHRA, etc.)\nEnsure compliance with cGMP, GDP, and global regulatory requirements\nDrive quality culture and continuous compliance improvements\nReview and approve quality system documentation and risk assessments\n\nQuality Investigations\nLead, review, and approve deviation investigations and CAPA\nEnsure robust root cause analysis and effective corrective/preventive actions\nDrive timely closure of investigations and escalation of critical issues\nUtilize advanced investigation tools and methodologies\nEnsure investigation quality meets regulatory expectations\n\nLeadership & General Responsibilities\nProvide technical guidance and mentoring to junior team members\nCoordinate with cross-functional teams for resolution of quality issues\nPresent critical quality decisions to leadership\nIdentify process improvement opportunities and drive efficiency initiatives\nEnsure timely closure of action items and commitments\nReport and escalate critical non-compliance issues\n\nHere Is What You Need (Minimum Requirements)\nB.
Pharm/M. Pharm/M.Sc.\nMaster's Degree: 4 - 5 years\nBachelor's Degree: 6 - 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facility\nChange Management process\nRisk assessments principles and tools\nValidation of lab equipment's\nDrug Product Process validations\nRegulatory requirements\nCompendial Changes\nKnowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.\nAdhering to Site Procedures and corporate polices\nPreferred Requirements\nStrong Interpersonal skills\nAbility to communicate effectively with all levels within the organization.\nCompliance driven approach, knowledge on cGMP and regulations.\nShould face national and international inspections such as USFDA, MHRA, TGA & WHO\n\nPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.\n\nTo learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .\n\nQuality Assurance and Control]]>
