Quality Assurance Manager

Role & responsibilities

Key Responsibilities

1. Quality Management System (QMS)

• Establish, implement, maintain, and improve the Quality Management System in line with global regulatory expectations.
• Ensure compliance with cGMP, WHO-GMP, US FDA 21 CFR Parts 210/211, EU GMP, and applicable ICH guidelines.
• Review and approve SOPs, specifications, protocols, validation documents, and quality records.
• Lead change management, deviation handling, CAPA, OOS/OOT investigations, and risk management activities.

2. Regulatory Audits & Inspections (Core Responsibility)

• Lead QA representative during FDA and international regulatory audits

  , including:
• US FDA
• EU GMP / EDQM
• UK MHRA
• TGA (Australia)
• Health Canada
• WHO / PIC/S
• Act as the

  single point of contact (SPOC)

  with regulatory authorities during inspections.
• Plan and execute

  pre-audit readiness programs

  , mock audits, and gap assessments.
• Lead preparation of audit documentation, site presentations, and inspection logistics.
• Manage

  inspection observations (Form 483, Warning Letters, GMP deficiencies)

  and ensure timely, scientifically sound responses.
• Oversee root cause analysis and implementation of corrective and preventive actions (CAPA).
• Ensure effective audit closure and long-term compliance sustainability.

3. Product Quality & Compliance Oversight

• Review and approve batch manufacturing and packaging records.
• Ensure effective handling of deviations, OOS, OOT, complaints, recalls, and product quality reviews (PQR/APQR).
• Ensure compliance with data integrity principles (ALCOA+).
• Oversee vendor qualification, audits, and quality agreements.

4. Team Leadership & Training

• Lead, mentor, and develop the Quality Assurance team.
• Conduct GMP and regulatory training programs for cross-functional teams.
• Foster a culture of quality, compliance, and inspection readiness across the organization.

5. Documentation & Data Integrity

• Ensure robust document control, archival, and retrieval systems.
• Implement and monitor data integrity controls across manufacturing, QC, and QA systems.
• Review validation and qualification documentation for facilities, utilities, equipment, and computerized systems.

6. Continuous Improvement & Risk Management

• Drive continuous improvement initiatives based on audit trends and regulatory expectations.
• Perform Quality Risk Management (QRM) using tools such as FMEA, HACCP, and risk assessments.
• Participate in management review meetings and provide quality metrics to top management.

Preferred candidate profile

Educational Qualification

• Bachelors or Master’s degree in Pharmacy / Pharmaceutical Sciences / Chemistry / Life Sciences.

Experience

• 12–18 years

  of progressive experience in Pharmaceutical Quality Assurance.

• Proven experience as a lead participant in multiple international FDA and regulatory audits

  , preferably covering

  more than one regulatory authority

  .
• Strong exposure to formulation manufacturing facilities (OSD, liquids, semi-solids, etc.).

Key Skills & Competencies

• Expert knowledge of WHO-GMP, US FDA, EU GMP, ICH, and global regulatory requirements.
• Hands-on experience handling FDA 483s and regulatory responses.
• Strong leadership, communication, and decision-making skills.
• Excellent documentation, investigation, and root cause analysis abilities.
• High level of integrity, compliance mindset, and regulatory discipline.
• Ability to interact confidently with auditors and senior management.

Preferred Attributes

• Experience in

  successfully closing critical audit observations

  .
• Exposure to data integrity remediation programs.
• Experience in handling contract manufacturing organizations (CMOs) and third-party audits.
• Strong understanding of quality culture building in regulated environments.

Authority & Accountability

• Authority to approve/reject materials, processes, and products based on GMP compliance.
• Accountable for overall QA compliance and inspection readiness of the site.
• Direct responsibility for audit outcomes and regulatory commitments.