Role Overview:

As the Head of Quality Assurance, you will serve as the final authority on quality compliance and regulatory excellence for our client's pharmaceutical manufacturing operations in Daman. You will oversee the entire quality lifecycle, ensuring that all products meet stringent global regulatory standards while fostering a culture of continuous improvement. You will work closely with plant leadership, regulatory bodies, and cross-functional department heads to mitigate risks, streamline quality systems, and ensure that the facility maintains an impeccable audit-ready status at all times. Your leadership will directly influence the company's ability to deliver safe, effective, and compliant pharmaceutical products to international markets.

Key Responsibilities:

- Direct the comprehensive Quality Assurance strategy to ensure adherence to cGMP, ICH guidelines, and international regulatory requirements across all manufacturing processes.

- Implement robust Quality Risk Management frameworks to proactively identify, assess, and mitigate potential quality deviations before they impact production or patient safety.

- Lead and mentor a large, multi-disciplinary quality team, fostering professional development and ensuring high performance in daily operations.

- Manage all interactions with regulatory agencies, including hosting and responding to inspections, audits, and inquiries to maintain the facility's license to operate.

- Oversee the validation and qualification programs for equipment, facilities, and processes to ensure consistent product quality and regulatory compliance.

- Drive the Quality Management System (QMS) by overseeing CAPA, change controls, deviations, and market complaints to ensure systemic issues are resolved permanently.

- Collaborate with supply chain and production stakeholders to ensure that raw materials, packaging components, and finished goods meet the highest quality benchmarks.

Required Skillset:

- Demonstrated expertise in managing complex quality operations within the pharmaceutical industry, with 20 - 30 years of progressive experience in leadership roles.

- Proven ability to navigate high-stakes regulatory environments, including successful track records with USFDA, MHRA, and other global health authority inspections.

- Strong proficiency in Quality Risk Management and the ability to translate technical quality data into actionable business strategies for senior management.

- Exceptional interpersonal skills, with the ability to influence stakeholders, negotiate with regulatory bodies, and lead large-scale organizational change.

- Advanced educational background in Pharmacy, Chemistry, or a related life sciences field, providing a strong technical foundation for complex decision-making.

- High level of adaptability and commitment to an on-site work environment in Daman, ensuring direct oversight of manufacturing quality and team performance.