Director, Product Quality Leader

Responsibilities

• Supports the formulation of the product control strategy and overall design of stability studies in alignment with the Process and Product Development teams and Quality management.
• Drives the development of product specifications and associated justifications.
• Defines bridging strategies for the implementation of new analytical methods during the course of the product development life cycle, ensuring sound scientific rationales are applied.
• Collaborates with QC management and/or contract testing organizations, defines methodologies to evaluate performance and trending of analytical methods.
• Partners with Quality Engineering to define appropriate statistical tools as needed.
• Evaluates data with respect to potential product impact.
• Escalates, as needed, to QC and QA heads in event of unexpected and OOS results. Provides recommendation on proposed path(s) forward and investigation approach.
• Represents Quality on CMC teams responsible for product development and manufacturing, internally or at CMO.
• Demonstrates the ability to translate complex process knowledge and understanding into robust implementation plans for product/program changes.
• Applies quality and process knowledge to support product transition from clinical to commercial, new product introductions and tech transfers.
• Serves as QC point person for OOS management and CAPA implementation at contract organizations.
• Oversees the authoring, reviews and revisions of technical registration documents and submissions to regulatory agencies.
• Partners and aligns with QC management and/or contract organizations on content of submissions.
• Partners with Regulatory Affairs and Quality to address responses to regulatory requests and comments.
• Supports Annual Product Review submissions.
• Ensures conformance to all regulatory requirements, including FDA and various international regulatory governmental bodies.
• Interacts directly with auditors/inspectors in support of PAI and GMP inspections.
• Represents the QC function on due diligence and external sites inspection activities.
• Collaborates with internal and external stakeholders to drive company objectives, to resolve issues and define escalation mechanisms, while ensuring team meets quality and compliance requirements.
• Engages in external technical forums to advance Allogene’s internal capabilities and influence external current positions.
• Show the capacity to communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
• Show the capacity to influence others through persuasive interactions and garner support for novel solutions where applicable.
• Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.

Qualifications

• Ph.D. degree in life Sciences with a minimum of 7-10 years of experience in the biotechnology industry.
• Equivalent combination of education and experience considered.
• Practical knowledge and solid understanding of biological drug development process from early development to product launch and support of commercial products.
• Sound knowledge of cGMP and regulatory compliance (US and other international agencies).
• Proven track record of successfully managing PAI and/or GMP inspections.
• Experience with analytical and biologicals methods development, optimization and validation, as well as stability programs.
• Strong knowledge of statistics and working experience with statistical and trending software such as JMP.
• Experience in managing and investigating deviations and CAPA implementation.
• Experience in dealing with regulatory agencies supporting regulatory filings.
• Experience with project management in a matrix organization.
• Strong leadership ability, interpersonal, communication, and influencing skills required.