Role & responsibilities

1. Quality Management Systems (QMS) & Governance

- Establish, maintain, and continuously improve the corporate QMS in compliance with global standards (ISO, GMP, Kosher, Halal).
- Oversee critical quality processes, including Change Control, Deviations, Out of Specification (OOS), Out of Trend (OOT), Risk Assessments, and CAPA (Corrective and Preventive Actions).
- Author, review, and approve critical QA documents, including Standard Operating Procedures (SOPs), batch records, and validations.
- Manage the product Stability Program, ensuring protocol accuracy, data review, and timely report generation.

2. Regulatory Affairs & Product Safety

- Direct the preparation, review, and maintenance of Safety Data Sheets (SDS) in compliance with global GHS regulations.
- Lead REACH-related compliance and maintain communications with regulatory bodies, customers, and suppliers.
- Ensure accurate issuance of regulatory, customer, and country-specific declarations.
- Oversee the creation and upkeep of specialized technical portfolios, including Pharma Tech Packs, Technical Data Sheets (TDS), and Certificates of Analysis (COAs).

3. Audit Management & Vendor Qualification

- Serve as the primary point of contact for all Internal, Customer, and Regulatory Audits (e.g., FDA, health authorities, ISO bodies).
- Direct the Vendor Qualification program, overseeing supplier audits, quality agreements, and periodic risk-based requalification.
- Ensure timely tracking and closure of all audit observations and non-conformances.

4.



Operational Excellence & Cross-Functional Leadership

- Partner with New Product Introduction (NPI) teams to ensure quality compliance during product launch phases within the SAP system.
- Collaborate closely with R&D;, Production, Sales, and Logistics to resolve high-priority quality complaints and shipping/regulatory queries within agreed timelines.
- Act as an advisor to the executive leadership team regarding compliance risks, product certifications (RSPO, OMRI), and strategic continuous improvement initiatives.

Technical Skills & Competencies

- Deep expertise in global regulatory frameworks (GHS, REACH, GMP, ISO).
- Hands-on proficiency with SAP (specifically Quality Management/QM modules).
- Strong understanding of analytical laboratory operations, stability testing, and tech pack compilation.

Expert-level knowledge of risk management tools (e.g., FMEA) and root cause analysis

Preferred candidate profile

Education & Experience

- Education: Masters or Bachelors degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.

- Experience: 12- 15+ years of progressive experience in Quality Assurance/Control within the Chemical, Pharmaceutical, or Allied industries, with at least 5 years in a leadership role.

Soft Skills

- Exceptional leadership, mentoring, and team-building capabilities.
- Analytical mindset with robust problem-solving skills under tight deadlines.
- Excellent communication and negotiation skills for interacting with international clients and regulatory inspectors.

📌 Head of Quality & Regulatory Affairs (Mumbai)
🏢 Rossari Biotech
📍 Mumbai