Associate Director, Analytical Quality & Compliance

Posted on Dec 10, 2018 by Bristol-Myers Squibb Company

New Brunswick, NJ 08901
Research & Development
5 Dec 2018
Annual Salary
Full-Time
The Associate Director in Analytical Quality & Compliance (AQ&C) will focus on the design through the implementation of Analytical Quality Standards based on global regulation, guidance and cGMPs. The AQ&C team currently provides quality assurance (QA) oversight for the analytical methods used in release, stability and in-process testing as well as reference standards and critical reagents for biologic products prior and including marketing authorization approval (BLA and/or MAA). The new scope for the AQ&C team extends our QA oversight to cover all analytical test methods for the BMS portfolio of clinical and commercial biologics and pharmaceutics products, not including the analytical activities as related to the routine execution of the test method (e.g. - OOS/OOT or deviations in a quality control laboratory). The Associate Director role will also manage 5-8 direct/indirect reports as the new scope for commercial biologics and clinical and commercial pharmaceutics gradually incorporates under AQ&C oversight. The direct/indirect reports will be accountable for the daily assessment activities of the BMS portfolio products' analytical method related documents against the current Quality System procedures and, as they are developed and implemented, the future Quality Standards. As the Associate Director role continues to grow within AQ&C, the incumbent will occupy a subject matter expert role for the BMS CMC community on the interpretation and implementation of the Quality Standards around the quality/compliance of analytical test methods.MAJOR DUTIES AND RESPONSIBILITIESAccountable to design, develop, author and implement Analytical Quality Standards (policies and global SOPs) that are phase-appropriate for the BMS portfolio of clinical and commercial biologic and pharmaceutic products based on regulation/guidance and other external or internal cGMP knowledge for Laboratory Controls (e.g. - 21 CFR 211; Eudralex Volume 4; Pharmaceutical Administration and Regulations in Japan; ICH guidelines; industry conferences; 483 notifications).Accountable for change control activities as related to updating the Quality Standards and global SOPs as per periodic review or in response to new regulations/observationsAccountable, as the Analytical Quality & Compliance subject matter expert on the analytical Quality Standards, to consult and provide to BMS personnel information to guide and implement the most appropriate quality/compliance solution for the situationLead, train and coach a team of 5-8 personnel to apply the Quality Standards to clinical and commercial biologics and pharmaceutical productsLead education initiatives across the clinical and commercial analytical functions to drive consistent usage of the Quality Standards for all biologics and pharmaceutical products throughout its lifecycle beginning in early stage product development through the end of commercial licensureKNOWLEDGE / SKILL / EDUCATIONBachelor degree in chemistry, advanced degree preferred especially as related to the analytical or physical analysis of pharmaceutics or biologicsA minimum of 12-15 years of relevant experience practicing a deep knowledge of regulatory expectations (GMP and cGMP) for analytics of pharmaceutical and/or biologics productsHighly knowledgeable in at least three of the following subject matter areas for either pharmaceutics or biologics: release, stability, and in-process test methods, reference standards and critical materials/reagents, method qualification/validation and transfer, compendial test methods and their verification, microbiological test methods, raw or starting materials, specifications and test standards, and stabilityA minimum of 5 years of experience in people management (team of at least 5 personnel) with a focus on developing talentKnowledgeable on pharmaceutic/biologic manufacturing, testing and global regulatory requirements (GMP and cGMP) for the lifecycle of a product beginning at Phase 1 through the end of commercial licensureExperience / Knowledge Desired:Development and implementation of quality standards and processes that are phase-appropriate in nature spanning clinical and commercial productsTechnical writing skills specifically related to authoring of procedural documentsDemonstrated influential leadership with Technical, Quality, and/or Regulatory functional areas to gain alignment between business partners and stakeholders with diverse perspectivesDemonstrated ability to work in a matrix environment, build strong relationships by being transparent and reliably deliver on commitments.Demonstrated ability to provide innovative and risk-based ideas or alternatives balancing speed, quality and risk including seeking new information and external insights without compromising complianceStrong and demonstrated strategic thinking capability coupled with project management skillsDevelopment and operations of robust testing and control strategies

Reference: 599254515

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