Deputy Manager / Manager – QA/QC | Randstad India | Hyderabad, Telangana
Job Description
Summary
Randstad India is hiring a Deputy Manager / Manager – QA/QC for CAR-T manufacturing in Hyderabad, Telangana. This role serves as the central QA authority for CAR-T product approvals across multiple point-of-care centers (POCs) in India. The ideal candidate will have strong experience in quality management, GMP compliance, and CAR-T product lifecycle oversight. You will lead QA/QC operations, collaborate with manufacturing and regulatory teams, and ensure adherence to global standards such as CDSCO, FDA, EMA, and ATMP regulations. This is a permanent position offering the chance to drive quality excellence in cutting-edge cell therapy manufacturing.
📊 Job Details at a Glance
| Job Title | Deputy Manager / Manager – QA/QC |
|---|---|
| Location | Hyderabad, Telangana |
| Employment Type | Permanent |
| Experience Level | 5–10 Years |
| Department | Quality Assurance / Quality Control (QA/QC) |
| Education | Bachelor’s or Master’s in Life Sciences, Biotechnology, Pharmacy, or related field |
| Shift | Day Shift |
| Reference Number | JPC – 111830 |
🛠️ Key Responsibilities
- Act as the central QA decision-maker for CAR-T product release across multiple Indian POCs.
- Develop, implement, and maintain QA/QC policies, SOPs, and inspection protocols specific to CAR-T manufacturing.
- Design and enforce inspection protocols for raw materials, in-process stages, and final products to ensure product integrity.
- Manage the site Quality Management System (QMS) and maintain compliance with GMP, CDSCO, FDA, EMA, and ATMP regulations.
- Oversee batch release, deviations, CAPAs, change controls, and risk assessments.
- Prepare for and lead internal and external audits, regulatory inspections, and quality reviews.
- Collaborate with cross-functional teams including Manufacturing, QC, and Regulatory Affairs to drive operational excellence.
- Lead continuous improvement initiatives and train staff on GMP compliance and quality culture.
✅ Required Skills & Competencies
- Strong knowledge of GMP, QA/QC, and CAR-T manufacturing processes.
- Experience with quality management systems, audits, batch release processes, and deviation management.
- Ability to collaborate with manufacturing, regulatory, and cross-functional teams.
- Strong analytical, problem-solving, and leadership skills.
- Knowledge of risk assessment, CAPA implementation, and regulatory compliance.
- Excellent communication and training abilities to promote quality culture.
🎓 Qualifications & Experience
- Bachelor’s or Master’s in Life Sciences, Biotechnology, Pharmacy, or related discipline.
- 5–10 years of experience in QA/QC roles, preferably in CAR-T or advanced therapy manufacturing.
- Experience in regulatory compliance and site quality management is highly preferred.
📢 Apply Now
Take the next step in your QA/QC career as a Deputy Manager / Manager – QA/QC with Randstad India in Hyderabad. Lead critical CAR-T manufacturing quality operations and ensure regulatory compliance across multiple POC centers.