Role: Quality Manager Biologics & Medical Devices
Location: Chennai, Tamil Nadu

Job Description

We are seeking an experienced Quality Manager to join our team in the Biologics and Medical Devices sector. The ideal candidate will have strong expertise in Quality Management Systems (QMS), regulatory compliance, GMP practices, and cross-functional collaboration across product development, manufacturing, and commercialization.

Key Responsibilities

- Support quality initiatives across biologics and medical device development, manufacturing, and commercialization.
- Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, GMP, 21 CFR Part 210/211, and applicable regulatory requirements.
- Review and approve quality documentation, including SOPs, validation protocols, batch records, deviation reports, CAPA, and change controls.
- Ensure compliance with regulatory requirements for biologics and medical devices, including documentation for inspections and audits.
- Collaborate with cross-functional teams to embed quality throughout the product lifecycle.
- Lead quality activities related to technology transfer, process validation, equipment qualification, and manufacturing scale-up.
- Apply risk management principles and support continuous quality improvement initiatives.
- Coordinate and support internal, external, customer, and regulatory audits.




- Work closely with manufacturing and external partners to ensure inspection and audit readiness.

Required Skills

- Strong knowledge of GMP, ISO 13485, 21 CFR Part 210/211, and relevant regulatory guidelines.
- Experience in Quality Management Systems (QMS), CAPA, deviation management, change control, and validation.
- Understanding of biologics manufacturing processes and/or medical device quality systems.
- Experience supporting technology transfer or manufacturing scale-up is an added advantage.
- Excellent communication, documentation, and stakeholder management skills.
- Ability to work effectively in a agile, cross-functional environment.

Experience

- 48 years of experience in Quality Assurance, Quality Control, or Manufacturing within the Biologics, Medical Devices, Biotechnology, or Pharmaceutical industry.

Education

- Bachelor's Degree in Science, Biotechnology, Pharmacy, Microbiology, Biochemistry, Biomedical Engineering, or a related Engineering discipline (Mandatory).

Preferred Industry

- Biologics, Medical Devices, Biotechnology, Pharmaceuticals

Please apply here for faster responses from the HR Team:

https://forms.gle/H9AcbJSXbAw65ux99

If you're hiring specifically for Biologics Quality Assurance (QA) rather than a combined Biologics & Medical Devices role, I can further customize the responsibilities and regulatory requirements accordingly.

📌 Quality Manager-Biologics&Medical Devices (Tamil Nadu)
🏢 Lifecell
📍 Tamil Nadu