Job Title : Manager/ Senior Manager

Were 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 new product introduction from a quality perspective.

Qualifications

- Bachelor’s or Master’s degree inPharmacy, Biotechnology, or related discipline.
- 8–12 yearsof experience in Quality Assurance, Compliance, or GMP roles within the pharmaceutical/biotech industry.
- Robust knowledge ofglobal regulatory standards (USFDA, EMA, MHRA, WHO)anddata integrity principles.
- Proven experience in managing audits, QMS, and CDMO compliance.

📌 Sr. Manager Quality Compliance & GMP Services (Maharashtra)
🏢 Biosimilar Sciences India
📍 Maharashtra