PHARMAFull-time
Associate Manager - Quality Compliance
By Admin · Quality Assurance & Quality Control
VIZAG (India)ONSITEPOSTED: 10/3/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Associate Manager responsible for Quality Compliance, Data Integrity, Market Complaints, investigations, CAPA and quality systems within a regulated pharmaceutical manufacturing environment.
ROLE DEFINITION & RESPONSIBILITIES
- •Partner with the Site Data Integrity Lead to strengthen Data Integrity culture
- •support Data Integrity Governance programs
- •conduct Data Integrity walkthroughs across GMP areas
- •identify ALCOA gaps and drive CAPAs
- •perform periodic Data Integrity compliance reviews
- •develop governance procedures, training and awareness programs
- •investigate Data Integrity and compliance concerns
- •perform root cause analysis and review CAPA effectiveness
- •prepare compliance metrics and management reports
- •manage receipt, evaluation, investigation, trending and closure of market complaints
- •coordinate cross-functional complaint investigations
- •support Annual Product Reviews, recalls, field actions and regulatory reporting
- •support regulatory inspections, customer audits and inspection readiness
- •participate in quality and continuous improvement initiatives
Reporting Hierarchy: Reports within Pfizer's site Quality organization and collaborates with Site Data Integrity leadership, manufacturing, QC, engineering, warehouse and other GxP functions
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, Microbiology or related discipline
- 8–12 years of experience in Quality Assurance, Quality Compliance, Data Integrity, Market Complaints or Quality Systems in the pharmaceutical industry
- experience in regulated sterile manufacturing environments
- exposure to global regulatory inspections including US FDA, MHRA, EMA, WHO, TGA and Health Canada
PREFERRED QUALIFICATIONS
- •Experience with eQMS, laboratory systems and manufacturing systems
- •experience with Data Integrity governance and GxP quality systems
- •experience with market complaints, recalls and Annual Product Reviews
REQUIRED VERIFIED SKILLS
Quality Assurance; Quality Compliance; Data Integrity; ALCOA principles; GxP; CAPA; root cause analysis; investigations; market complaints; quality systems; eQMS; regulatory inspections; US FDA; MHRA; EMA; WHO; TGA; Health Canada; sterile manufacturing; inspection readiness; regulatory reporting; Annual Product Reviews
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Equal opportunity employment; quality-focused and patient-centered work environment; opportunities to contribute to compliance and continuous improvement
Salary not disclosed in the supplied job posting; compensation should be confirmed during the application process.
ORGANIZATION CONTEXT & CULTURE
Pfizer is a global pharmaceutical company focused on developing and delivering medicines and vaccines, with a strong emphasis on patient safety, quality, scientific innovation and compliant operations.
TEAM SIZE: Global enterprise, 100,000+ employees (inferred)
INDUSTRY: Biopharmaceutical / Healthcare
Culture: Patient-focused, science-driven and risk-based quality culture emphasizing compliance, integrity, innovation and continuous improvement.
EXPECTED CAREER ROADMAP
Opportunity to develop expertise in pharmaceutical Quality Compliance, Data Integrity governance, regulatory inspection readiness, market complaints and quality systems while collaborating across GxP functions.
APPLICATION ADVISORY
Emphasize 8–12 years of pharmaceutical Quality Assurance/Compliance experience, sterile manufacturing exposure, Data Integrity and ALCOA knowledge, CAPA/investigation expertise, market complaint management and experience supporting global regulatory inspections.
RECOMMENDED TRAINING
1/5
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