QA Manager, Raw Materials Suppliers – Raleigh/Direct Hire
Our client, a Raleigh-based biopharmaceutical company that is developing cutting-edge therapies based on its proprietary gene-editing technology, is actively recruiting for a very capable, self-directed and knowledgeable candidate to assume a key role on its Quality Management team.
This is a global company that is developing immunotherapies to target and eradicate cancer cells. Products are manufactured at its cGMP-compliant facility in North Raleigh. This QA Manager will drive all Quality efforts related to Raw Materials Suppliers.
Key things to note:
- Company has several products in development – from discovery through early clinical stages. The company is in start-up mode and right candidate will bring Quality experience from emerging pharma/life science settings.
- This QA Manager will focus on Quality related to Raw Material suppliers. Extensive audit experience, including managing audit responses, will be essential.
- This QA Manager will supervise a small team. Seek hands-on Manager who is also a committed developer of people.
- Gene editing/therapy background would be valuable, but client will also candidate candidates with experience with biologics, cell therapies, etc.
- Travel is estimated at 25%, both domestic and international
Position will involve establishing and implementing all QA efforts related to GMP and High-Quality-Grade Raw Materials activities. Specific responsibilities will include:
- Participate in developing, maintaining, and improving the Quality System within the GMP area.
- Develop and implement the Supplier Management System.
- Manage the quality events linked to the GMP and High-Quality-Grade Raw Materials, such as Out of Specification, deviation, non-conformity, change, and lead investigation, CAPA implementation.
- Draft or review and approve GMP and High-Quality-Grade Raw Materials Quality SOPs.
- Lead risk assessment of GMP and High-Quality-Grade Raw Materials and suppliers.
- Review and approve GMP and High-Quality-Grade Raw Materials’ specifications.
- Formally approve the GMP and High-Quality-Grade Raw Materials for use. Maintain the Approved Supplier List.
- Review and evaluate suppliers for the quality aspects, set up and review of Quality agreement/procedures.
- Prepare audit plans and audit/risk mitigation plans as needed.
- Perform routine and non-routine QA audits to include: supplier sites, processes, systems. Document to assure QA compliance with regard to all internal procedures as well as quality and regulatory guidelines.
- Communicate and report (verbally and in writing) audit outcomes to the organization. Escalate issues as required.
- Manage and/or deliver yearly GMP Raw Materials training for internal staff.
- Proactively assist the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections.
- Participate in drafting and review of relevant sections for IND/CTA.
This QA Manager will be responsible for maintaining expert knowledge in quality and regulatory requirements and GMP guidelines and ensuring that the requirements are implemented accordingly internally at Company and at suppliers.
- Bachelor’s Degree in Life Science and 8 years of relevant QA experience within the pharmaceutical industry, ideally in a gene therapy/editing and/or biologic, cell therapy setting.
- Practical experience in regulatory inspection preparation and conduct
- Substantial audit experience within a GMP setting, with particular expertise in raw material supplier audits
- Familiarity with tests and techniques used for biologics including microbial load, microbial identification, endotoxin, sterility, cell culture, nutritional adequacy, aseptic technique, flow cytometry, ELISA, cell-based assays, potency testing, working in an isolator, etc.
- Experience with quality systems including change control, deviations, risk assessments, batch record review, batch release, and quality metrics as well as developing test methods
- Results- and goal-oriented
- Longevity and impact in previous roles
Finally and critically, we seek a candidate who will thrive in this emerging, dynamic setting. We seek a self-starter and agile thinker who can adapt to fast-changing needs and who brings an open and innovative approach to the workplace every day.
This is an immediate need and Direct Hire opportunity. Compensation will be generous.
Please forward Word resume for prompt consideration. Local candidates targeted at this time.