Description
The Associate Director, Quality Control is responsible for the companies Quality Control activities in support of all aspects of development and commercial operations for small and large molecule APIs, DPs, and medical devices ensuring compliance with regulatory obligations and international GMP/quality standards.Essential Accountabilities
- Direct quality control activities at contract laboratories and contract manufacturing operations.
- Lead, direct, and provide Quality Control support to ensure that development/commercial objectives and supply chain needs are met.
- Provide QC support to ensure successful outcomes in regulatory filings, communications, meetings, and inspections.
- Ensure compliance with regulatory, international GMP, and quality standards. Ensure laboratory exceptions (OOS investigations, deviations), changes, and complaints are managed in a compliant and timely fashion.
- Manage the Stability program with the CMO's for all The companies products: Raw Material/DS/DP
- Collaborate with external partners to ensure The companies QC needs and requirements are fully represented across the global organization and internally liaise with Global Technical Operations and Supply Chain, QA, and Regulatory Affairs.
Key Responsibilities
Direct Responsibility for QC management or oversight of the following areas:
- Management of the company's commercial contract test/development laboratories and associated QTA's as the main point of contact.
- Maintaining and requalifying reference standards associated with The companies API and drug products
- Leading OOS/OOT investigations (review of QC chromatograms and lab investigation) for The companies
- The companies lead for managing compendial updates on all products (methods and specifications).
- Raw Material/DS/DP/Placebo specification generation and revision
- Stability data review and statistical analysis lead for The companies products
- Analytical Method Transfers/Validation lead for The companies for Protocol/Report generation and approval with all CTL/CMOs
- Analytical Method Development and trouble shooting lead for The companies with all CTL/CMOs
- Contract Test Laboratory audits and site visits (raw data review)
Qualifications
- Sc., MSc or equivalent in chemistry, biochemistry, pharmaceutical science, or related field.
- 10-15 years progressive experience as individual contributor and manager/supervisor of quality control (or related analytical development, pharmaceutical development, or manufacturing) function.
If you are interested in this great opportunity and have the appropriate skill set and experience please contact me Anna Mooney or apply below with an up to date CV.