Job Summary: The senior product quality executive position requires an individual with strong technical expertise in Biologics manufacturing to provide quality oversight of upstream and downstream operations conducted at Contract Manufacturing Organizations (CMOs). This role is critical in ensuring that manufacturing activities are conducted in compliance with GMP, internal quality standards, and regulatory requirements while maintaining a strong focus on product quality throughout the production lifecycle.
Responsibilities:
Manufacturing Oversight
- Provide quality oversight for Drug Substance and Drug Product (DP) manufacturing activities at CMOs.
- Ensure manufacturing operations adhere to approved Master Batch Records, Standard Operating Procedures, and regulatory requirements.
- Review and assess critical in-process parameters, deviations, and any potential impact on product quality.
- Support timely resolution of quality-related issues and ensure decisions prioritize product quality and compliance.
Quality Review & Documentation
- Ensure that manufacturing deviations, OOS/OOT results, and non-conformances are properly documented, investigated, and closed in a timely manner.
- Participate in root cause analysis (and ensure corrective and preventive actions are effectively implemented.
- Review and approve batch-related documentation and quality records as required.
Process & Product Knowledge
- Maintain a strong understanding of process development and scale-up.
- Support technology transfer and PPQ activities from a product quality perspective.
- Cross-Functional Collaboration
- Collaborate with regulatory affairs, CMC as well as with CMO quality counterparts.
- Contribute to quality risk assessments and decision-making related to manufacturing operations.
- Support audits, inspections, and product-related investigations to ensure alignment with corporate and regulatory expectations.
Qualifications:
- Bachelor's or Master's degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or related life sciences discipline
- At least 5 years of relevant GMP experience in biopharmaceutical manufacturing
- Hands-on knowledge of upstream culture and downstream purification processes
- Strong understanding of EU GMP / PIC/S GMP regulations
- Ability to interpret technical manufacturing data and identify potential quality risks
- Excellent communication skills for effective collaboration with internal and external stakeholders
- Willingness to travel and work at CMO sites during manufacturing campaigns
