The Quality Assurance (QA) manager will establish and manage in collaboration with the QA specialists within the parent company, UCB, the overall Quality Management System (QMS) governing GxP activities for Handl Therapeutics’ gene therapy product programs.
- Establish and manage the overall company QMS with associated policies and procedures to assure that from discovery to (pre-)clinical, the company’s operations and products are compliant with applicable global GxP regulations and guidelines.
- Establish and manage the QA, document control and change control systems as they pertain to internal activities and to outsourced manufacture, testing, review, release and disposition of plasmids and gene therapy products.
- Provide expert oversight, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports.
- Establish and manage systems for the reporting, investigation and resolution of deviations, OOS and OOT encountered during GMP activities, including as required Corrective and Preventative Actions and Material Review Boards.
- Lead negotiations and completion of the Quality Agreements with CDMOs and other GxP contract service providers.
- Monitor and periodically review compliance to established quality standards and report metrics, findings and recommendations to the Leadership Team.
- Collaborate across departments to drive quality and compliance, providing required GxP training and review.
- Act as a the linking pin between local needs based on the size of company & the applied science and the practices & policies within the parent company.
- You have at least obtained a BSC in biological sciences or a related discipline and a minimum of 7 years of QA experience in the biotechnology or pharma industry, ideally with innovative biologic products.
- You have a proven track record of successful QA oversight of CDMOs and Contract Testing Organizations up to commercial production.
- You possess strong analytical and fact-finding abilities.
- In-depth knowledge and proven application of FDA, EMA, GMP and ICH regulatory requirements is required.
- You have strong interpersonal and collaborative management skills.
Contact Hanna Lammens at +32 492 89 76 19 or via firstname.lastname@example.org