Manager/Sr Manager, Quality Assurance (Biologics) – Emerging Company/Top $
Our client, an RTP area specialty pharmaceutical company in high growth mode, is actively recruiting for an exceedingly sharp candidate to lead Quality Assurance efforts for its portfolio of pharmaceutical products, with particular focus on its biological products.
This is a clinical stage company with several products in the later stages of development. The RTP office is being expanded to meet increased demand, and the future is very bright.
This Quality Manager, in partnership with the Director of QA, will be responsible for building and managing all Quality efforts including risk analysis, Quality planning, SOP writing, CAPA processes, etc. We seek an exceedingly capable Quality professional who, with limited direction, start-up time and ongoing supervision, will be able to lead a top-notch Quality Assurance program.
Key things to note:
- Role focuses on cGMP compliance, although this Manager may also contribute to other Quality initiatives
- Company relies upon 3rd party vendors for Manufacturing. Right candidate will understand the idiosyncrasies of managing Quality in an outsourced-to-CMO model
- Position will begin as an individual contributor role. Management duties relate to overseeing work done by vendors, not subordinates
- This is an emerging company in which policies and procedures are still being developed and enhanced. Seek hands-on and innovative manager who will significantly contribute to QA strategies and tactics.
- Travel is estimated at 25% (domestic and international)
Specific duties will include:
- Oversee suppliers
- Compile and review Contract Manufacturing Organization executed batch record documents
- Review lot-related deviations, CAPAs, change controls and specifications
- Lot disposition
- Archive supplier batch documentation to the internal archiving system
- Support inspection preparedness activities within company and GMP vendor partners
- Provide guidance, advice and support for GMP operations Quality Compliance matters.
- Contribute to development of Quality Systems as relevant, such as creation of SOPs related to batch release or other topics, etc.
- Participate in the development of metrics, reporting, reviewing and trending of cGMP-related Quality Key Performance Indicators (KPIs) in support of the QMS
- Proactively monitor the performance of CMOs, including implementation of improvements
This is a critical role and Company will pay industry-leading wage to attract and retain an outstanding candidate.
Targeted candidate will offer a related degree and 5+ years of Quality Assurance experience in a GMP regulated setting. Biologics bkgd will be important.
Other priorities include:
- Substantial knowledge of relevant standards FDA (regulations, ICH guidelines, and cGMP regulations
- Experience contributing to the development of Quality systems, procedures and standards for an emerging pharma company
- Experience managing Quality in an outsourced setting
- Understanding of Quality practices related to CMC requirements
- Record of impact and longevity in previous roles
Finally, we seek a hands-on, make-things-happen manager; one who will work exceedingly well in a dynamic and empowered setting. This is an exciting company at a very exciting time. Seek an industrious, curious and operations- savvy candidate who will thrive.
Please forward Word resume for prompt consideration. Local candidates only.