Working with the Head of Biologics Quality and the Sr. Director of External Manufacturing, this role is responsible for all aspects of supplier quality (material, services, and finished goods). This includes, but is not limited to compliance, lot disposition and Annual Product Review (APR) for externally manufactured Drug Substance (DS) and Drug Product (DP). As the scope of these responsibilities includes a broad range of materials, the Head of Biologics Supplier Quality must be well versed in all US/EU GLP/GMP requirements and agency expectations.
Specific responsibilities include, but are not limited to the following:
* Development, implementation and continued improvement of policies and processes for external quality oversight of investigational and commercial DS and DP. (e.g. Allergan review / approval of BPR?s, Supplier Quality System oversight, Supplier Quality Unit Qualification Program, supplier metrics, supplier steering committee meetings, identification of supplier quality initiatives)
* Chair Material Review Board (MRB) activities, and make the final disposition
* Approve supplier Annual Product Reviews where appropriate
* Maintain clear supplier performance visibility, by providing routine updates to Biologics Manufacturing Senior Leadership on suppliers and supplier related activities
* Approve and ensure supplier adherence to all Quality Agreements (e.g. provide audit, inspection and monitoring support to evaluate overall cGMP compliance)
* Partner with suppliers to develop compliant solutions / improvements for Allergan products / processes
* Establish and maintain a supplier quality database and all KPI?s / CPP?s
* Function as the liaison between suppliers and Allergan Regulatory Affairs
* Partner with internal Subject Matter Experts (SME?s) to ensure that the supplier deviations? technical rationale and corrective actions are acceptable and appropriate.
* Supplier risk management ? partner with the Sr. Director of External Manufacturing to mitigate supplier and supplier program risks.
Note: This position requires periods of extensive travel and can be located in Irvine or Campbell, CA.
BA / BS in a life science or engineering discipline, or a strong technical background with a minimum of 15 years' experience in a cGMP setting, five (5) years' in Quality Assurance or related discipline, and a minimum of two (2) years? direct experience in external quality oversight. Prior experience as a Qualified Person (QP) is not required, but is a strong plus.
* Solid knowledge of regulatory requirements for biopharmaceutical processing, GLP and cGMPs.
* Provide quality oversight and management of multiple suppliers, with diverse capabilities and deliverables.
* Must have strong collaborative skills and work well in matrixed organizations.
* Excellent problem solving skills, and experience resolving / explaining complex deviations / production discrepancies.
* Strong interpersonal, oral and written communication skills with the ability to create a high level of teamwork and team / individual accomplishment.
* Detail oriented with proven organization and coordination skills. Ability to manage multiple projects in a dynamic situation while maintaining the ability to troubleshoot and ?think outside the box."
* Individual will work with select agent information. Access to and use of select agent information requires compliance will all applicable Federal laws, regulations, and guidances.