Role Objective:

The General Manager - Quality Assurance (Injectables) is responsible for ensuring that all injectable products meet global regulatory standards, quality expectations, and patient safety requirements.

- The role focuses on strengthening Quality Management Systems (QMS), driving continuous improvement, leading compliance initiatives, and fostering a strong quality culture across the site. The candidate will provide strategic leadership and collaborate cross-functionally to align quality goals with overall business objectives.

Desired Candidate Profile:

- M.Sc / MBA with a strong academic background in life sciences or allied fields.

- Minimum 16+ years of progressive QA leadership experience, preferably including site-level Quality leadership.

- At least 10+ years of experience supervising, managing, and directing teams in QA functions.

- In-depth knowledge of cGMPs, global regulatory requirements, and health authority guidelines.

- Strong technical proficiency in aseptic operations, injectable manufacturing, and quality systems.

- Proven ability to lead quality operations in a dynamic, fast-paced manufacturing environment.

- Exceptional leadership, communication, and stakeholder management capabilities.

Key Responsibilities

- Lead and oversee the entire Quality Assurance function for the injectable manufacturing site.

- Ensure full compliance with global regulatory standards, internal SOPs, and quality frameworks.

- Develop, strengthen, and monitor Quality Management Systems (QMS) to enable operational excellence.

- Collaborate closely with Operations, Regulatory Affairs, Clinical Operations, Supply Chain, and Finance to harmonize quality objectives.

- Review and approve validation protocols, master manufacturing records, deviations, CAPAs, and change controls.

- Lead and manage regulatory inspections and internal/external audits; ensure timely closure of observations.

- Drive continuous improvement initiatives focused on product quality, process efficiency, and compliance maturity.

- Mentor, guide, and develop a high-performing QA team, ensuring accountability and professional growth.

- Oversee training programs for personnel on quality systems and regulatory expectations.

- Support risk assessment, mitigation strategies, and decision-making to safeguard product integrity and patient safety.

Functional Skills Required:

- Deep understanding of global cGMP regulations and ICH/WHO/FDA/EMA quality guidelines.

- Strong command over QMS, audit methodologies, data integrity, and risk-based approaches.

- Experience in deviation handling, CAPA lifecycle management, and change control processes.

- Solid understanding of aseptic processes, sterile manufacturing, and injectable product quality attributes.

- Ability to evaluate technical, scientific, and analytical data for strategic decision-making.

- Strong track record of leading regulatory inspections and ensuring sustained compliance.