Life Sciences Jobs at Syngene | Head – QA Biologics
Syngene International Limited, a leader in contract research, development, and manufacturing, is seeking a visionary Head – QA Biologics to oversee all Quality Assurance operations within its Biologics Business Unit in Bengaluru. This critical Life Sciences Job requires a Master’s or Ph.D. in a relevant biotechnology jobs discipline and extensive mid-to senior-level leadership experience within Quality Control/Assurance in the Biologics sector. The role involves managing all facets of QA for both Mammalian and Microbial manufacturing plants and driving operational excellence initiatives. This is a strategic opportunity to advance a Syngene career.
- Job Title: Head – QA Biologics
- Location: Bengaluru, Karnataka
- Division: Essential Functions
About The Company
Syngene is a leading integrated scientific services provider, supporting the full spectrum of research from early discovery to commercial supply. The company places paramount importance on safety, expecting all employees to adhere to safety guidelines, contribute to EHS mindset development, and ensure compliance with quality standards at all times.
Core Purpose and Division
This leadership role is within the Quality Assurance team of Syngene’s Biologics Business Unit. The incumbent will be responsible for providing strategic oversight and implementing sustainable operational excellence initiatives within the QA department.
Key Role Accountabilities
The incumbent is expected to be a Thought Leader, providing executive oversight across diverse QA functions:
- Comprehensive QA Oversight: Oversee all Quality Assurance operations, including Analytical QA (Analytical, Bioassay, Microbiology), Engineering QA, Manufacturing QA (IPQA), Quality Management Systems (QMS), Vendor Quality Management, and Audits and Compliance.
- Plant Management: Oversee quality operations for both Biologics Manufacturing Plant 1 (Mammalian) and Plant 2 (Microbial) facilities.
- Audits and Inspections: Act as Point of Contact for hosting inspections and audits from regulatory authorities, clients, and internal audit committees. Ensure timely communication of responses and CAPA effectiveness to all stakeholders.
- QMS Documentation: Review and approve critical QMS documents (Quality Manual, Site Master Files, Validation Master Plans, Quality Agreements, SOPs) and facilitate timely closures of all QMS records (Change controls, OOS, OOT, Deviations, CAPA, LIRs).
Experience, Skills & Qualifications
- Education: Master’s degree in Biochemistry/ Microbiology/ Biotechnology or Ph. D.
- Experience: Must be a Thought Leader with at least few years of mid-to senior-level leadership experience within the Quality department of a Biologics facility.
Technical and Management Skills
- Technical Depth: Hands-on experience in executing Analytical and Bioanalytical method validations, method transfers, testing and release, and stability operations. Knowledge of Microbiological methods execution and validation.
- Compliance: Rich knowledge on regulatory guidelines, Quality risk management, and cross-contamination strategy.
- Operational Excellence: Experience on operational excellence initiatives; Lean Six Sigma – Black belt or Green Belt (preferred).
- Communication: Excellent verbal and business communication; Client focus and strong cross-functional collaboration skills.
Core Responsibilities (Focus on Quality)
- Ensure implementation and sustenance of Data Integrity in all QA operations.
- Overall responsible for ensuring adequate staffing and training of personnel.
- Periodic review and presentation of Quality Metrics and MIS reports.
- Review and approve Manufacturing records (BMR, PDR, Specifications, Test methods, Batch release documents, COA, etc.).
If an applicant is an experienced QA leader with deep technical expertise in Biologics manufacturing (Mammalian/Microbial), method validation, and regulatory compliance, this strategic Life Sciences Job is an ideal fit. They should apply now to take charge of Quality Assurance for Biologics and elevate their Syngene career in this critical biotechnology jobs leadership role.
