Sr. Manager / Associate Director, Quality Control
Source: Talent GB
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients , join us!
Click to know more about GSK Biopharm.
The Sr. Manager / Associate Director, Quality Control is responsible for leading the Quality Control function at GSK in support of CMC development activities and providing guidance to the Quality Control staff. The Associate Director will oversee operations pertaining to QC testing at contract testing laboratories and contract drug substance and drug product manufacturing sites. This responsibility includes vendor oversight, project management, data review, and exceptions management. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This position includes assisting with QC checks and preparation of regulatory filings (INDs and NDAs).
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Development and implement cGMP compliant procedures crucial to the successful operation of the Quality Control function.
Provide both technical and operational chemistry expertise for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations.
Provide leadership and direction to development project teams to ensure product quality guidelines are consistently met.
Manages and develops the performance of direct reports by setting clear expectations, as well as resolving conflicts.
Manage drug substance and drug product analytical testing at contract laboratories including investigation and resolution of analytical test failures (OOS and atypical results)
Review QC raw data and assist in batch release.
Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports
Assemble data packages in support of specification and method changes associated with GSK products
Represent QC in cross-functional teams with internal and external customers
Contributes to appropriate sections of IND/IMPD and NDA/BLA/MAA filings, and approves various quality documents (internal and external) associated with GSK products
Participate in vendor and internal audits as needed
Contribute to company quality systems
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
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