Job Title: Group Manager – Manufacturing Compliance
Location: Visakhapatnam (Vizag), India
Employment Type: Full-Time
Posted: 4 Days Ago
Job Requisition ID: 4943677
About the Role:
We are seeking a Group Manager – Manufacturing Compliance to lead and strengthen compliance initiatives within our pharmaceutical manufacturing operations. This role is critical in ensuring that all manufacturing activities meet global regulatory requirements and Pfizer’s high-quality standards. You will oversee inspection readiness, corrective and preventive actions (CAPAs), and quality risk management (QRM), while guiding upstream compliance teams to drive continuous improvement.
Key Responsibilities:
Ensure timely implementation of corrective and preventive actions (CAPAs) from regulatory inspections, third-party, or corporate assessments.
Conduct Regulatory Observations Network Assessments (RONA) to identify gaps and ensure CAPAs are executed within agreed timelines.
Coordinate inspection readiness activities with site teams and global subject matter experts.
Maintain and update inspection readiness trackers, including preparation of slide decks for site and leadership meetings.
Lead governance meetings and provide timely updates to management regarding any delays.
Provide data and metrics for inspection readiness and regulatory inspection actions.
Lead the upstream compliance team, providing guidance in CCF, CAPA, QRM, and training initiatives.
Monitor the CAPA lifecycle to ensure on-time closure and trend metrics for continuous improvement.
Develop and execute strategies to improve compliance and maintain systems to track performance against targets.
Minimum Requirements:
Master’s degree in Sciences or Pharmaceutical Sciences.
Minimum 10 years of experience in pharmaceutical manufacturing compliance.
Strong knowledge of current Good Manufacturing Practices (cGMP) and corporate quality systems.
Proven experience in people management and cross-functional collaboration.
Excellent written and verbal communication skills.
Proficiency in MS Office, Word, Excel, Access, Project, and Trackwise or equivalent quality management tools.
Preferred Qualifications:
Strong analytical and problem-solving abilities.
Ability to work independently and make sound decisions.
Excellent organizational and time management skills.
Experience interacting with regulatory agencies during audits.
Proven ability to drive continuous improvement initiatives within manufacturing and quality systems.
Work Location: On-Premise – Vizag, India
Why Join Us:
This role offers an opportunity to lead manufacturing compliance initiatives in a global pharmaceutical environment, ensuring patient safety, regulatory adherence, and operational excellence. You will work closely with leadership and cross-functional teams to strengthen quality systems and drive meaningful impact.
Equal Opportunity Statement:
We are an equal opportunity employer and comply with all applicable employment legislation in each jurisdiction in which we operate.
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