Senior Technical Head - Pharma (15-16 yrs)

Key Responsibilities:

- Quality Assurance & Compliance

- Oversee and maintain quality assurance processes across all plants.

- Ensure strict adherence to FDA regulations, Schedule M, and other applicable compliance standards.

- Handle Non-Standard Quality (NSQ) drug-related matters, including investigations, recalls, and documentation.

- Prepare and manage legal and compliance documentation for regulatory submissions.

Audit & Regulatory Management:

- Manage and coordinate regulatory audits, including ROW (Rest of the World) audits and internal quality audits.

- Ensure compliance with national and international regulations and guidelines.

- Lead audit readiness initiatives and ensure successful outcomes in regulatory inspections.

Legal & Liaison Work

- Handle legal matters, including liaising with external legal counsel, regulatory bodies, and other stakeholders.

- Address and resolve legal cases related to product compliance, NSQ issues, and recalls.

- Ensure compliance with the Drugs and Cosmetics Act and other applicable regulations.

- Technical Oversight

- Provide technical guidance to plant teams, ensuring alignment with corporate quality and compliance objectives.

- Develop and implement strategies for continuous improvement in technical and quality processes.

- Serve as a technical expert for internal and external stakeholders.

Qualifications & Experience:

Education:

- B.Pharm (Bachelor of Pharmacy) is mandatory.

Experience:

- Minimum 10 years of experience in quality assurance, regulatory affairs, legal compliance, and related functions in the pharmaceutical industry.

Expertise:-

- Proven experience handling ROW audits and managing FDA compliance.

- Strong knowledge of the Drugs and Cosmetics Act and Schedule M regulations.

- Experience in recall documentation, NSQ drug management, and legal compliance.

Skills & Competencies:

- Strong regulatory knowledge and legal acumen.

- Excellent communication and documentation skills.

- Ability to manage cross-functional teams and collaborate effectively with internal and external stakeholders.

- Strong problem-solving and decision-making abilities.

Other Details

Base Location: Dehradun or Mumbai (with travel as required).

Relocation Assistance: Provided for suitable candidates.

Reporting: Directly to the Head Office Directors, with a dotted line to plant management.