Quality Control Manager - Pharmaceuticals
Innovative pharmaceutical start up in Burlington, VT area
Own Quality Control both internally and externally
About Our Client
Our latest client is a rapidly growing, specialty pharmaceutical start-up based in the Burlington VT area. While this company is well-established, it operates as that of a start-up environment with employees wearing many hats and take on varying responsibilities. It has also been voted the US Top 10 Life Sciences companies of its type in 2019.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Oversees all laboratory processes and systems (e.g in-process and release testing programs, raw materials, Environmental Monitoring, Stability program, method validation, retain program, and microbiological method suitability).
- Drives compliance at both internal and external laboratories
- Oversee implementation and maintenance of QC instruments, methods, cGMP documents, sample handling, and applicable electronic systems.
- Manages department resources (human resources and financial resources).
- Ensure analytical, microbiological and environmental monitoring programs adhere to current regulatory expectations.
- Ensure QC support to Planning, Operations, and other department for timely release of the products to the clients.
- Provides strong leadership and guidance to laboratory operations and personnel.
- Manages robust laboratory investigations (analytical, micro and environmental monitoring OOS/OOT) to ensure root cause analysis and effectiveness checks are performed.
- Support Annual Product Quality Review (APQR) activities.
The Successful Applicant
- BS/MS or PhD in Life Sciences and minimum of 3 years of QC Management experience overseeing a laboratory environment.
- Experience with environmental monitoring and aseptic processing.
- Knowledge of USP and FDA regulations.
- Understanding of a quality system, including the training, deviations, CAPA management, etc.
- Demonstrated success with written and verbal communication along with good problem-solving skills, and ability to work in a fast-paced environment.
- Excellent project management skills and attention to detail.
- Exceptional at handling multiple, competing demands in a time-sensitive manner.
- In-depth knowledge of current Good Manufacturing Practice principles. Able to identify breach of current Good Manufacturing Practice principles and provide suggested corrective actions.
- Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes teamwork, collaboration, motivation, and team building
What's on Offer
- Excellent base salary
- Bonus opportunity
- QC Head role reporting into senior leadership
- Growth opportunity - seeking a high-level QC Manager ready to take a next step into Director
- Free lunch Friday and Wednesday breakfast
- Very competitive benefits package
- Flexibility of a start-up environment
- Strong innovative culture and atmosphere
- Relocation offered for qualified candidates