QC Director/Senior Director

At Proclinical, we are seeking an individual to fill the role of QC Director/Senior Director, based in Cambridge, MA. The Director of QC will support the portfolio of clinical development programs to ensure timely delivery of clinical supplies and will assemble, review and trend release, IPC, and stability data, generating reports as necessary to support specifications and expiry settings.

Responsibilities

• Ensure successful technical transfer, method validation and routine GMP and GLP testing in collaboration with Analytical Development and external QC test labs.
• Support the development and management of QC specifications for in-process, release and stability testing programs.
• Ensure all testing is conducted in accordance with all relevant internal and external standards, and direct aspects of contract GMP and GLP testing.
• Support the development of QC systems and SOPs.
• Review and trend QC data, generating stability and other trending reports as necessary.
• Support QC deviations, investigations, analytical method performance trending and work with external testing laboratories on root cause analysis and investigation actions.
• Participate in regulatory agency inspections and assists in observational resolutions.
• Prepare appropriate sections of regulatory filings and performs data integrity reviews as necessary.

Skills And Qualifications

• BA in Chemistry, Biochemistry or related with 10+ years of relevant industry experience.
• Experience validating methods and monitoring commercial method performance.
• Experience drafting protocols, data reports and QC/QA compliance documents required.
• Experience with statistical analysis of analytical data and stability studies preferred.
• Must be willing to travel domestically and internationally up to 15-20%.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 6468786308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.