Product Quality Lead
- New Haven, CT
The Product Quality Lead (PQL) is to provide quality oversight of new device and combination clinical and commercial products from introduction throughout the product and design control lifecycle. As the product quality expert, the PQL will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation. The PQL is the quality liason between Regulatory Affairs and Operations to ensure regulatory compliance with design control activities and documentation, technology transfer to manufacturing and QC testing processes. The role enables efficient communication and decision making related to the quality and design control of our combination products.
The position reports into the Director, Product Quality Leader.
- Develops the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation and Technology Transfer
- Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Design and Development Plan, User Requirement and Design Input Specifications, Design Outputs, Verification and Validation Protocols and Reports, Risk Management deliverables, Design Reviews, and Design History File management
- Develop with input from GPD and Product Quality, Design Control and Risk Management procedures and templates to support Combination Product Development projects
- Provide Quality Engineering input on developing CTQ criteria and specifications for Combination product raw materials, in-process and finished product acceptance activities
- Evaluate internal and CMO initiated design changes for impact to Combination Product DHF and support client design change controls as needed
- Assist in quality review of CMC sections of Regulatory submissions and response to queries
- Provide input on and review of shelf-life testing and stability programs for Combination product(s)
- Facilitates global changes with respect to the product and design control
- Supports Health Authority inspections and compliance
- B.Sc. degree in biological /chemical sciences, biomedical/mechanical engineering, or other related technical degree or equivalent experience in regulated industry.
- Preferable 10 - 15 years’ cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
- Combination product and device delivery system experience
- Design for Six Sigma (DFSS) trained and certified a plus
- Demonstrated ability in decision making, problem solving and project management.
- Collaborate, negotiate, influence and lead in a matrix organization
- Excellent communication and interpersonal skills
- Proven record in demonstrating agility
- Flexibility to travel in support of the role
- Knowledge of process development and quality systems with a strong business and technical acumen would be an advantage
Tuesday, August 20, 2019