Head - Corporate Quality - Pharma API

Our client is one of the top pharma API firms based in India.

Role: Head Corporate Quality

Location: Ankleshwar, Gujarat

Role Overview: To lead our Corporate Quality function and is critical in ensuring the highest standards of quality and compliance across our API operations. The ideal candidate will bring substantial experience in the API industry, with a proven track record in setting up and managing corporate quality functions.

Key Responsibilities:

- Leadership and Strategy: Develop and implement the corporate quality strategy aligned with the company's goals. Lead and mentor a team of quality professionals to drive excellence in quality management across all API operations.

- Quality Systems Management: Oversee the development, implementation, and maintenance of quality systems and procedures to ensure compliance with international regulatory requirements, including USFDA standards.

- Audit Management: Manage and coordinate internal and external audits. Ensure successful handling of USFDA audits, addressing any findings or observations effectively.

- Regulatory Compliance: Ensure all processes and practices are compliant with relevant regulatory requirements and industry standards. Maintain up-to-date knowledge of regulatory changes and implement necessary adjustments.

- Continuous Improvement: Drive continuous improvement initiatives to enhance quality systems and processes. Utilize data and performance metrics to identify areas for improvement and implement corrective actions.

- Stakeholder Communication: Liaise with internal and external stakeholders, including regulatory agencies, to communicate quality-related information and ensure alignment with corporate quality objectives.

Ideal Candidate Profile:

- Experience: 15-20 years of experience in the API industry, with a focus on corporate quality roles. A minimum of 4-5 years in a corporate quality leadership position is required.

- Audit Experience: Demonstrated experience in handling 3-4 USFDA audits with a successful track record of compliance.

Industry Background: Previous experience in renowned API organizations

Due to time constraints, only shortlisted candidates will be connected. We will be evaluating the responses to the questions below to see the fitment.