Director, Quality Assurance (Product)
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POST DATE 9/14/2016
END DATE 10/15/2016
Menlo Park, CA
JOB DESCRIPTIONDermira seeks a Associate Director / Director, Quality Assurance Operations to support the manufacture and analysis of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) and labeling of clinical and commercial supplies and analysis of finished products at Contract Research Organizations (CROs) to ensure that Dermira s drugs are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves quality oversight of CMOs/CROs and liaison of quality related issues with Dermira s Chemistry, Manufacturing and Control (CMC) and Clinical Teams and functional management. The scope of the position encompasses oversight of all aspects of drug manufacture through clinical development and into commercial phase. Oversight of GLP activities and associated CROs is also a requirement of this role.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The successful incumbent will be the QA Representative on CMC and Non-clinical Teams responsible for drug manufacture, testing, labeling, and non-clinical activities. The position will require regular interaction with the Head of QA at both the CMOs/CROs and Dermira on matters concerning the product quality and CMO/CRO GMP/GLP compliance. This may include, but is not limited to:
Responsible for QA operational oversight of CMO/CRO s and suppliers.
Interaction with CMO/CRO senior leaders to assure that Dermira QA / GMP/GLP interests are met and that relationships are properly maintained.
Establishing Quality Agreements with CMO/CRO s.
Accompany CMC and Non-clinical on technical visits when required.
Review and approve Master Batch Record (MBR) in compliance with GMP regulations, regulatory filings and quality agreements.
Review and approval of executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation certifying batches as GMP compliant.
Review and approval of validation protocols, raw data, and reports (Method, Process, Cleaning, etc.)
Review of non-clinical protocols, amendments, data, and study reports to ensure compliance to GLP regulations.
Manage change control, deviation, and investigation processes in place at Dermira and the oversight of such systems at the CMO/CRO.
Review and approval of changes, deviations, and investigations at CMOs/CROs.
Management of the batch release process at Dermira including issuance of COR s.
Collaborates with the Director of QA Compliance on quality system reviews and gap analyses as part of CMO/CRO selection, approval, and on-going evaluation.
Serves as back-up to compliance group to conduct GMP/GLP compliance audits of contractors and suppliers.
Review CMC and Non-clinical sections of regulatory filings.
Provide support in the preparation for and during governmental regulatory agency inspections of Dermira and Dermira s contractors. Manage war room activities.
Manages the document control group and associated systems.
Develop, refine, and manage internal Dermira Quality Operation Systems for Commercial Manufacturing.
Develop and maintain product trending analysis and metrics. Present Metrics and associated findings in annual management reviews and reports.