As an Associate Director - Quality Lead CSV/CQV, you will play a pivotal role in ensuring the highest standards of quality and compliance in our validation activities. This is an exciting opportunity to lead a dedicated team and contribute to the success of our cutting-edge projects.
Your Core Responsibilities
- Lead and manage a team of QA Engineers and CSQSs, including contractors, to develop, support, and maintain Quality Assurance for Validations processes and systems.
- Ensure validation and qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes in compliance with cGMP, industry standards, and regulatory expectations.
- Review and approve validation documentation and associated data for conformance to SOPs, specifications, and other applicable acceptance criteria.
- Oversee and approve events/deviations, investigations, and change evaluations during qualification/validation activities, ensuring adherence to SOPs and cGMP requirements.
- Implement, manage, and review SOPs related to QA Validation activities.
- Provide support during regulatory inspections, offering QA Validations expertise to maintain facility validation status.
- Coordinate QA Validations activities to ensure schedule adherence and timely delivery of project deliverables.
- Manage and develop the QA Validations team, including performance management, recruitment, and training.
Who You Are
You are ready if you have:
- B.Sc or B.Eng in a Scientific or Engineering discipline (e.g., biochemistry, chemistry, engineering).
- Extensive experience in Quality Engineering/Quality Assurance/Quality Validations for Vaccine/Biologics or related pharmaceutical manufacturing in an FDA/EU regulated environment.
- Proven experience in leading and developing teams.
- Experience liaising with and responding to regulatory inspectors and client auditors.
- Thorough understanding of cGMP validation requirements for manufacturing facilities, including facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.
- Strong technical aptitude and deep knowledge of GxP regulations and industry standards applicable to validation (e.g., EUGMP, FDA, ISO, GAMP, ISPE, ASME, BPE), along with troubleshooting and problem-solving skills, including formal root cause analysis methods and tools.
- Experience with continuous improvement processes, demonstrating a proven ability to enhance operational efficiency and drive positive change.
Nice to have, but not essential:
- Independent and self-motivated.
- Able to multi-task in a fast-paced, dynamic working environment.
- Green belt or Lean Six Sigma qualification.
