Senior Quality Assurance Manager

Role Objective: A key objective of this position is to ensure the effective implementation of cGMP, SOPs, and robust execution of validation and qualification activities while maintaining a strong Quality Management System (QMS) in alignment with regulatory requirements. The role aims to drive continual improvement, uphold regulatory compliance, and support the organization in achieving consistent product quality.

Desired Candidate Profile: Master’s or bachelor's degree in science, pharmacy, engineering, or a related life sciences discipline. Minimum of 12–16 years of progressive experience in quality assurance within sterile/injectable or regulated manufacturing environments. Strong knowledge of cGMP, QMS, validation, qualification, and regulatory guidelines. Experience leading IPQA and validation functions across multiple manufacturing units is preferred. Proficiency in electronic QMS platforms (e.g., TrackWise, DMS) and ERP systems (e.g., SAP).

Roles & Responsibilities:

IPQA & Validation Activities Ensure that cGMP practices and SOPs are followed during all stages of manufacturing, filling, and packaging, including line clearance, in-process checks, and online documentation (BMR/BPR). Lead IPQA and validation activities, including team training on sampling, line clearance, dispensing, manufacturing, filtration, filling, visual inspection, labeling, packaging, pre-dispatch, and qualification processes. Identify, assess, and evaluate oversight activities in consultation with departmental heads. Ensure batch execution activities comply with BMR/BPR/SOP requirements and regulatory expectations. Review GMP documents, including SOPs, BMR/BPR/MFR, artworks, stability protocols, validation protocols, audit schedules, training calendars, specifications (RM/PM/FP/IP), and test procedures. Review Certificates of Analysis (CoA) and batch release documentation in SAP. Participate in external audits and support audit readiness and compliance. Review and approve vendor audit schedules, vendor qualifications, and evaluations for RM, PM, SPM, and TPM. Ensure effective implementation of vendor-related changes through change control. Verify vendor agreements and certification details and coordinate renewal processes. Initiate and close PRs in TrackWise for various modules, including MRM and internal audits. Ensure adherence to QMS processes, including change control, deviations, market complaints, OOS, and CAPA in DMS and TrackWise. Participate in investigations of deviations, OOS, and complaints; perform risk assessments and define/track CAPA implementation. Monitor facility areas (clean rooms, water systems, utilities) and report non-conformances to concerned departments and QA leadership. Perform procedural gap assessments against regulatory expectations and ensure corrective adherence. Conduct IPQA and validation activities in accordance with regulatory guidelines and internal procedures. Update and approve the Bill of Materials (BOM) in SAP. Review documents such as VMP, SMF, and the Quality Manual. Review Management Review Meeting (MRM) data and prepare minutes of meeting (MoM). Ensure fulfillment of regulatory and marketing requirements related to products. Coordinate validation activities as per schedule with internal teams and external agencies. Process validation-related quotations, prepare payment plans, coordinate invoices, and authorize payments post completion and approval. Execute and review validation activities, including HVAC, process validation, transport validation, sterilization validation, equipment qualification, temperature mapping, and instrument calibration as per the VMP schedule. Ensure compliance with regulations such as ISO 13485, WHO, CMDCAS, MDR, 21 CFR Part 820, and other applicable standards. Provide required documentation to regulatory departments as per agency requirements.

Authority Authorized to prepare, review, and approve GMP documents and artworks. Authorized to review and approve VMP and SMF. Authorized to act as a designee for AGM–QA (Head QA).

Functional Skills Required: Strong understanding of cGMP, QMS elements, and validation concepts. Expertise in sterile manufacturing processes, IPQA, and compliance management. Knowledge of regulatory requirements for global markets. Proficiency in handling audits and regulatory inspections. Hands-on experience with electronic QMS platforms and SAP. Strong documentation, review, and approval capabilities.

Behavioral Skills Required: Leadership and team development capabilities. Strong analytical, decision-making, and problem-solving skills. Excellent communication and cross-functional collaboration. High attention to detail and commitment to compliance. Ability to work under pressure and manage multiple priorities.

Team Size to Be Handled: Lead and supervise a team of 8-10 team members, reporting to the AGM–QA.

Important Links: Website:

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Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.