Senior Executive - Quality Compliance

Key Responsibilities:

Supplier Quality Management:

• Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO).
• Lead supplier qualification, requalification, and performance monitoring programs.
• Conduct risk-based assessments and ensure supplier categorization based on product and service criticality.

Auditing & Compliance:

• Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers.
• Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers.
• Maintain audit schedules, records, and ensure timely reporting.
• Maintenance of Approved Supplier List / GMP documents / Supplier files

Quality Agreements & Documentation:

• Coordinate the drafting, negotiation, and maintenance of Quality Agreements with suppliers.
• Review supplier documentation such as CoAs, TSE/BSE statements, stability data, and regulatory filings for compliance.
• Ensure all supplier documentation is up to date and archived as per data integrity principles.

Regulatory Support:

• Support regulatory inspections and provide supplier-related documentation during audits.
• Monitor regulatory changes and ensure suppliers are aligned with evolving GMP expectations.

Cross-Functional Collaboration:

• Work closely with Procurement, R&D, Manufacturing, and Regulatory Affairs to ensure supplier issues are identified, communicated, and resolved efficiently.
• Participate in cross-functional quality risk assessments and supplier development programs.

Continuous Improvement:

• Drive quality improvement initiatives with suppliers to enhance performance and reduce quality-related risks.
• Track and report quality KPIs related to suppliers and initiate corrective actions when targets are not met.

Qualifications and Experience:

• Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
• Experience: Minimum 6–8 years of experience in Quality Assurance / Quality Compliance within the pharmaceutical industry, with at least 2 years in a Supplier Quality Assurance role.
• Preferred: Exposure to regulatory inspections (e.g., USFDA, MHRA, TGA), and experience in working with global suppliers.

Key Skills & Competencies:

• Strong knowledge of cGMP, ICH Q7/Q10, WHO, and global regulatory requirements.
• Experience in conducting and managing supplier audits.
• Excellent communication and negotiation skills.
• Strong documentation and analytical skills.
• Proficiency in MS Office tools and electronic QMS ,SAP ERP systems.
• Ability to work independently and manage multiple priorities under tight timelines.

Key Performance Indicators (KPIs):

• % of on-time completion of supplier audits and qualification activities.
• % of CAPA closures within agreed timelines.
• Supplier non-conformance rate (trend analysis and reduction).
• Compliance score during internal and regulatory audits.