Quality Assurance Manager (APIs/Pilot Plant) – Emerging Biotech/Top $$
Our client, an NC company that is establishing itself as a global leader in the hemp-based health and science market, is actively recruiting for a very sharp and industrious candidate to drive and oversee all Quality Assurance matters.
The company is partnering with its clients to customize hemp-based raw ingredients for the production of pharmaceutical and other FDA-regulated products. They operate a GMP- and EU-GMP-compliant facility and seek a candidate with broad and deep knowledge of current regulations and practices.
Company will pay industry-leading wage to attract a star.
Key Things to Note:
- This is a science-based company dedicated to understanding the medical and therapeutic value of cannabinoids extracted from hemp.
- Theirs is the finest quality industrial hemp and is grown and harvested by NC farmer partners.
- The facility operates in accordance with FDA CFR 210 and 211, EU GMP Volume 4, ICH Q7, Q8, Q9 and Q10. Experience with APIs and related regulations is required.
- This is a broad-based role responsible for all aspects of Quality Assurance in the facility, including contributing to the DMF and IND submissions. Related experience and knowledge will be important.
- The company employs a Digital Quality Management System. Experience with on-line document management systems is expected.
- This is a start-up setting in which policies, procedures and practices are still being developed and finetuned. We seek a builder who brings knowledge, ingenuity, drive and focus.
- Position is located in Wilson, NC. Some flexibility of schedule is available.
This QA Manager will be responsible for ensuring that all quality management functions are maintained according to GMP requirements, working directly with the VP of Compliance and Quality.
- GMP compliance, (to all relevant regulatory requirements), of all products through the product development, regulatory approval and commercialization processes.
- Lead role, in conjunction with outside consultant, in preparation of all DMF filing requirements.
- Review of master and executed batch records and Quality testing for release of commercial and development products.
- Conduct of investigations into GMP related issues or problems associated with audits, batch records and complaints.
- Assist with management of manufacturing deviations, out-of-specification results, temperature excursions and investigations.
- Ensure adequate root cause analysis as well as identification and implementation of effective CAPAs
- Preparation and review of QA change control documentation.
- Creation and/or revision of SOPs governing GMP QA activities.
- Vendor audits supporting product manufacturing and packaging/labeling.
- Preparation of monthly quality metrics for periodic review meetings
Targeted candidate will offer a scientific degree and 5+ years of relevant GMP experience in a biopharmaceutical supplier or manufacturing operation. Strong preference for candidates with API manufacturing experience.
Other priorities include:
- Solid understanding of pharmaceutical quality assurance principles including global cGMP requirements, 21 CFR 210 and 211, and other relevant regulations. ICH Q7, Q8, Q9 and Q10 important
- Experience contributing to DMF and/or IND submissions
- Experience managing Quality documents with digital platforms (Master Control, etc.)
- Outstanding project management and organizational skills
- Keen analytical ability and problem-solving skill
- Record of impact and growth
Finally, we seek an industrious and self-directed candidate who will be a significant contributor to this company that is doing innovative work in a rapidly-expanding field; A candidate who can thrive without a roadmap and will bring the knowledge, savvy and drive to work through ambiguity and complexity to achieve desired results.
This is an immediate need. Please forward Word resume for prompt consideration. Local (or nearby) candidates targeted.