General Manager - CQA - Formulations - OSD & Sterile
Job Description
Role : Lead CQA ( Formulations - OSD & Sterile)
Designation : General Manager
Department : CQA
Role Objective:
Direct the strategic implementation, governance, and advancement of the corporate Quality Management System (QMS) across internal facilities and Contract Manufacturing Organizations (CMOs).
This executive position ensures global regulatory compliance, risk mitigation, and quality excellence through cross-functional leadership and external partnership management. Utilizing expertise in QA, QC, and Microbiology, the lead will drive audit readiness.
KEY RESPONSIBILITIES
QMS Approval & Compliance: Review and approve core Quality Management System elements (including Change Controls, Deviations, Investigations, Market Complaints, Product Recalls, Specifications, BMR/MFR, Stability Protocols/Reports, Validation Master Plans, and APQRs) to ensure a continuous state of regulatory compliance.
Market Complaint & Counterfeit Investigation: Spearhead investigations into market complaints and hub observations; define and track the effectiveness of CAPA. Coordinate with local FDA, cross-functional teams (CFT), and marketing to resolve identified counterfeit product issues.
Recall & NSQ Tracking: Manage, execute, and monitor product recall processes and track Not of Standard Quality (NSQ) matters until complete closure.
Contract Manufacturing Oversight: Ensure stringent adherence to Good Manufacturing Practices (GMP) across USV’s Loan License (LL) and Third Party (TP) contract manufacturing locations by approving audit agendas and conducting quality/cause audits.
Regulatory & Guideline Implementation: Coordinate with sites and CFTs to seamlessly deploy new guidelines and mandatory requirements (e.g., Revised Schedule M, Psychotropic substances, QR Codes, DEG, and EG compliance).
Quality Agreements & Governance: Review and align Quality Agreements with customers and legal departments. Organize Site Quality review meetings, prepare corporate Quality Review Committee (QRC) Minutes of Meetings, and track compliance via event notifications.
Audit Support & Client Notifications: Support manufacturing plants during customer and regulatory inspections. Manage proactive customer notifications regarding regulatory inspection outcomes and resolve subsequent technical queries.
Budgeting & Project Management: Coordinate, budget, and approve qualification documents for new QMS projects and system upgrades.
Regulatory & Marketing Liaising: Assist the regulatory department with registration documentation and collaborate with international marketing to resolve emerging market product queries.
People Development: Identify technical training needs for corporate QA personnel and impart training to new and existing team members.
STAKEHOLDER INTERACTION
Type of Interaction: Internal
Interaction with: Senior Vice President – CQA , Cross-Functional Teams (CFT) , Plant/Site Quality Heads , Legal Department , Regulatory Affairs Department , International/Domestic Marketing Teams , and Corporate QA Personnel.
Nature of Interaction: Reporting on compliance health ; collaborating on guideline implementation, quality agreements, and project budgeting ; driving Site Quality reviews ; and conducting corporate training sessions.
Type of Interaction: External
Interaction with: Customers/Clients , Local FDA/Regulatory Authorities , and Contract Manufacturing Organizations (Loan License & Third-Party Vendors)
Nature of Interaction: Investigating market complaints , coordinating on counterfeit product investigations with local FDA , auditing LL/TP sites , negotiating Quality Agreements , and issuing inspection status notifications.
JOB REQUIREMENTS
Professional Experience and Relevant Skills
Experience: A minimum of 20 - 25 years of experience within the pharmaceutical industry, with exposure to Corporate Quality environments.
Technical Expertise: Strong domain expertise in Quality Management Systems (QMS), Market Complaint Handling, Vendor Qualification, and Quality Review Committees (QRC). Profound knowledge of international GMP standards, formulation processing, validation principles, and regulatory frameworks.
Skills: High-level strategic auditing capabilities, cross-functional project management, crisis and recall management, fiscal budgeting for quality projects, and technical mentoring/training capability.
ACADEMIC QUALIFICATIONS & CERTIFICATIONS
Educational Qualification: Master’s / Bachelor’s degree in Pharmacy (M.Pharm / B.Pharm)