Director, Quality Assurance (Commercial Products) – Emerging Pharma/Top $$
Our client, a Raleigh area pharmaceutical Company in high-growth mode, is actively recruiting for a highly strategic and knowledgeable candidate to drive all Quality Assurance functions. This is a critical role and Company will pay excellent wage to attract and retain an excellent candidate.
Key Things to Note:
- This Company has two marketed products – but it is still relatively small. Seek Quality leader who understands the start-up/emerging business culture and who also brings extensive experience building Quality programs for commercial products.
- This is an all-encompassing Quality role that will focus on commercial but will also involve clinical, CMC, etc. Products are both oral solid dosage and injectables. Seek broadly-skilled candidate who, if not expert in all, will bring the initiative and competence to become expert quickly.
- This Company uses CMOs, CDMOs, etc. for development and production functions. Experience driving Quality in an outsourced model will be important.
- This Director can be located in the NC or FL corporate offices. The Quality staff (~ 4 for now) are in FL. The CMOs are in multiple locations. Seek candidate who can effectively manage staff and/or vendors remotely. Travel is estimated at 25%.
- This Company is growing exponentially, and it is expected to continue. Seek candidate who knows how to scale Quality Systems in a rapidly-expanding setting. Experience implementing electronic records systems would be valuable.
Position will involve providing strategic guidance on Quality Assurance and ensure that all Quality requirements are met in a timely fashion. This includes:
- communication within the company and with external vendors
- implementing and maintaining the functions of Quality Systems for the company’s products, processes and practices
- managing the compliance of the vendors and suppliers
- Develop a comprehensive Quality strategy for existing products as well as new products for the U.S. and ex-U.S. markets
- Manage Quality Systems and QA duties, including proactive monitoring of the performance of CMOs and other vendors
- Ensure quality, completeness and compliance of documentation from Company and external vendors
- Develop and design database tracking and management for all Quality documents
- Provide leadership and training to the QA staff
- Lead the development of metrics, reporting, reviewing and trending of Quality Key Performance Indicators (KPIs) in support of the QMS
- Develop a collaborative and supportive relationship with all departments, internally and externally, especially with Manufacturing, Quality Control and Analytical organizations in a proactive and professional manner.
Targeted candidate will offer a related scientific degree and 10+ years of Quality Assurance experience in a GMP regulated setting. Commercial products experience is essential.
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
- Supervisory experience, including experience overseeing remote employees
- Understanding of Quality practices related to CMC requirements
- Record of impact and longevity in previous roles
Finally, we seek a strategist who will be both forward-thinking and hands-on. We seek someone who brings exceptional knowledge of Quality standards, regulations and best practices and will be extremely savvy about how to incorporate them into this growing and complex company.
This is an exciting time and the future is very bright. Seek an industrious, smart and can-do Quality Leader who is eager and prepared to contribute.
Please forward Word resume for prompt consideration. Local candidates targeted.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.