Senior Director, Commercial Product Quality

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: June 15, 2022

Job Description:

Senior Director, Commercial Product QualityJob DescriptionEveryone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!SummaryWe are seeking a Senior Director, Commercial Product Quality to lead the Product Quality organization for Kite's commercial products. You will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet late-stage clinical and commercial product goals. As a product expert in Quality, this role has the responsibility to lead the group of commercial Product Quality Leads (PQLs) and the Stability Leads for technical expertise and project support for the Quality and Compliance aspects of the product throughout its life cycle. You and/or your team members will be the Quality representative on the Operations Team, developing and driving CMC strategies in the Technical Operations organization, operationalizing the product strategy and leading the alignment within the broader Quality organization and with the sites. You will help to define the operational Quality and Compliance strategy with the team who will be active in the execution of the strategies supporting the commercial Operations Team.As a product expert in Quality, the Commercial Product Quality Lead role has responsibility for working directly with Operations Leaders, Quality Control (QC), Regulatory Affairs, Process Development (PD), Quality Assurance (QA), Qualified Persons, and Manufacturing on the resolution of issues and implementation of strategies associated with cell therapy products. This includes topics related to technology transfers, manufacturing process improvements, in-process control and critical quality attribute trends, analytical methods (implementation of new methods, transfers, validation, performance and improvements), establishment of and revisions to final product and starting material specifications, reference standards, importation testing, investigations, change controls, regulatory submissions, annual product reviews, continued process verification, risk assessments and regulatory inspections related to product(s). Your work will driveinitiatives intended to ensure the overall product health.Duties & Responsibilities:

• Provide Quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies.
• Represent Quality on the Operations Team. Communicate the product strategy and drive alignment within the broader Quality organization and with the sites.
• Execute/drive product strategies through strong quality and scientific leadership related to technology transfers, global regulatory filing strategies, analytical method improvements, stability, product specifications and program improvements.
• Support operationalizing theoretical concepts (e.g. product strategies) into actionable plans and execute those plans with successful outcomes.
• Negotiate plans with regulatory authorities and internal multi-functional teams to obtain the optimal product quality position for life cycle management
• Sponsor the global Commercial Product Quality Team, lead by the PQLs.
• Develop strategies for regulatory submissions with the Operations Team. Author sections of regulatory submissions and communications, as needed. Review and approve CMC submissions and regulatory communications to assure overall quality and scientific soundness.
• Lead the development and revision of final product, product intermediate and critical process material (e.g., viral vector) specifications in conjunction with Process Development, Analytical Development, QC, Translational Medicine and Clinical Development teams. Drive decision making and alignment for final product and viral vector specifications through the Specification Committee (comprised of Technical Operations and Regulatory Upper Management).
• Support development of the stability strategy of the product
• Lead/Sponsor the annual product review or product quality review (APR/PQR) process for commercially marketed products
• Support product quality data monitoring programs (i.e., continued process verification). Drive the connection with the APR process.
• Accountable for policies and SOPs related to product and process material specifications, stability and the APR processes.
• Manage ownership or Quality approval of change controls, deviations and CAPAs related to product and process material specifications, stability and the Annual Product Reviews.Basic Qualifications:--- Advanced degree and 12+ years' experience in biotech / biopharma, technical operations OR--- Master's Degree and 12+ years' experience in biotech / biopharma, technical operations OR--- Bachelor's Degree and 14+ years' experience in biotech / biopharma, technical operations OR--- High School Degree and 18+ years' experience in biotech / biopharma, technical operationsPreferred Qualifications / Skills:
  • 10+ years working in a regulated environment (either direct GMP or technical support)
  • Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment.
  • Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
  • Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
  • Must be able to manage and prioritize workloads of staff members, who themselves must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Experience with authoring or review of biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation, highly desired.
  • Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
  • Ability to work and navigate within an evolving scientific and regulatory environment.
  • Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions, preferred.
  • Experience in direct interaction with regulatory agencies/Boards of Health during inspections
  • Understanding of biologic product development and manufacturing principles.
  • Knowledge of cGMP and filing regulations, guidelines, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.
  • Previous experience working on a cross-functional team in a matrix environment is a plus.Does this sound like you? If so, apply today! Share: Job Requisition ID R0029118 Full Time/Part Time Full-Time Job Level Director Click below to return to the Gilead Careers siteClick below to see a list of upcoming eventsClick below to return to the Kite, a Gilead company Careers site

Keywords: Gilead Sciences, Inc., Santa Monica , Senior Director, Commercial Product Quality, Executive , Santa Monica, California