Commercial Product Quality Lead

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: September 22, 2022

Job Description:

For Current Kite Pharma Employees and Contractors:Please log onto your to apply for this job.Job DescriptionWe are seeking a Senior Manager, Quality Assurance - Commercial Product Quality Lead for Kite's commercial products. - You will lead the Annual Product Review (APR) / Product Quality Review (PQR) process for Kite's commercial products and viral vector. - This position will provide the opportunity to an ambitious cross-functional team leader, who can drive process maturity, thinking and acting with a future growth and globalization mindset.Duties & Responsibilities (including, but not limited to):

• Global lead for the APR / PQR process for Kite's commercial products
• Accountable for the overall quality of the reports, leading a team of cross-functional subject matter experts (SMEs), driving the compilation of the report to defined standards and ensuring the report is completed within established timelines
• Present APR / PQR reports and process to regulatory agency inspectors or auditors, as requested
• Using technical expertise to guide the team with direction, resolving concerns, training and mentoring SMEs with authoring sections
• Author the executive summary. - Convey meaningful APR / PQR conclusions, identifying themes or trends across the topics and defining action items. -
• Communicate with management about the APR / PQR process and team expectations. - Provide periodic updates on and progress until completion. -
• Work with upper management to facilitate their review of the report and ensure their concerns are addressed
• Share APR outcomes and updates on action items at the Quality Management Review meetings
• Owner of the SOP and report templates. - Drive APR / PQR process improvements, proactively identifying and implementing efficiencies, leveraging other Kite systems, such as continued process verification (CPV).
• As needed, support other PQLs who lead the product strategy and life cycle management of Kite's commercial products and viral vector. - This may entail leading projects in support of the product strategy. - This may also involve authoring regulatory submissions / communications.Basic QualificationsPhDORMaster's Degree and 6+ years' experience in biotech / biopharma, technical operationsORBachelor's Degree and 8+ years' experience in biotech / biopharma, technical operationsORHigh School Degree and 12+ years' experience in biotech / biopharma, technical operationsPreferred Qualifications
  • 3+ years working in a regulated environment (either direct GMP or technical support)
  • Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills 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
  • Ability 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 and/or review of technical reports, APR / PQR reports, biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation
  • 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
  • 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
  • Previous experience working on a cross-functional team in a matrix environmentKite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at . -For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, -genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact -for assistance. -Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.---For more information about equal employment opportunity protections, please view the - poster.Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:Please log onto your to apply for this job.

Keywords: Gilead Sciences, Inc., Santa Monica , Commercial Product Quality Lead, Other , Santa Monica, California