We’re Hiring: Sr. Manager – Compliance & GMP Services | Navi Mumbai

Company: BSS India (Biosimilar Sciences India LLP)

Location: Navi Mumbai

Experience: 8–12 years

Are you passionate about driving quality excellence and ensuring regulatory compliance in a dynamic biopharmaceutical environment?

BSS India is looking for an experienced Senior Manager – Compliance & GMP Services to lead our quality and compliance operations and ensure adherence to global regulatory standards.Key Responsibilities

? Quality Management System (QMS):

- Lead the implementation and continuous improvement of the Quality Management System (QMS) in line with cGMP, ICH, and international guidelines.

- Oversee Deviation, CAPA, Change Control, Risk Management, and related QMS elements.

- Monitor metrics and present quality trends through Management Review Meetings (MRMs).

? Compliance & Audit Readiness:

- Ensure site and system compliance with USFDA, EMA, MHRA, WHO, and other global standards.

- Coordinate and support internal/external audits and regulatory inspections.

- Drive inspection readiness and implement CAPAs from audit findings.

? Manufacturing & Documentation:

- Provide compliance oversight for Drug Product manufacturing activities—formulation, filling, visual inspection, and packaging.

- Ensure robust Aseptic Practices, process simulations,



and validation (cleaning, equipment, process).

- Oversee GMP documentation and data integrity in line with ALCOA++ and GDP principles.

? Risk & CAPA Management:

- Implement proactive risk management frameworks.

- Review root cause analyses and CAPA effectiveness for deviations and non-conformances.

? Training & Quality Culture:

- Develop training programs to enhance QMS and regulatory understanding.

- Foster a culture of continuous quality ownership across teams.

? Supplier & Vendor Management:

- Manage supplier qualification, audits, and quality agreements with vendors and CDMOs.

- Collaborate with procurement to ensure external quality compliance.

? Continuous Improvement:

- Drive QMS efficiency through digital tools, automation, and Lean/Six Sigma initiatives.

- Support technology transfer and recent product introduction from a quality perspective.

Qualifications

- Bachelor’s or Master’s degree in Pharmacy, Biotechnology, or related discipline.

- 8–12 years of experience in Quality Assurance, Compliance, or GMP roles within the pharmaceutical/biotech industry.

- Strong knowledge of global regulatory standards (USFDA, EMA, MHRA, WHO) and data integrity principles.

- Proven experience in managing audits, QMS, and CDMO compliance.

📌 Manager/ Senior Manager (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai