Senior Director, External Quality

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: March 7, 2023

Job Description:

For Current Kite Pharma Employees and Contractors:Please log onto your to apply for this job.At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.Job DescriptionWe are seeking a highly motivated leader to join us as a Senior Director External Quality within Kite's Quality Organization. The Senior Director will report to the Vice President of Product & Distribution Quality. The Senior Director will play a pivotal role within our technical operations organization with accountability to assure quality amongst Kite's external partnerships. Scope includes contracted service providers such as development and manufacturing organizations (CMO/CDMO), contract testing labs (CTLs) and Quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space.The Senior Director External Quality will have opportunities to work and share knowledge with leaders and partners across Kite's Global Technical Operations organization (e.g. Process Development and MSAT, Regulatory, Quality, Manufacturing, and Supply Chain), as well as international partners, multiple CMO/CDMO and CTL. The ideal candidate will have excellent motivational skills (career development and mentor); technical skills (biologics/gene and cell therapy manufacturing and testing operations, international GMP regulations, and drug development life cycle); strategic, and network-based thinking (tact, quality agreement/contract negotiation, project management).This position will be based at Kite's corporate headquarters in Santa Monica, CA.Responsibilities of the Senior Director of External Quality include:

• Leading the External Quality team that includes the QA/QC functional support for CMO/CDMO, CTL and Strategic Partnerships and ensuring effective cross-functional coordination and implementation of quality capabilities.
• Providing recommendations for the best-suited partner (excluding Strategic Partnerships) to meet Kite's strategic targets and quality risk profile. Consulting on supply and quality agreements, onboarding and tech transfer plans for each partner.
• Quality Leader on joint steering committees with Executive leaders across contracted services providers and partnerships, as determined.
• Ensuring team advance progress on key projects/initiatives; manage critical issues or risks that emerge and implement solutions; meet production demand/testing timelines; and monitor KPIs related to performance of Kite's contracted services providers and strategic partners
• Providing guidance and direction for CMO/CDMO and CTL related issues and implementation of quality systems - SCARs, CAPAs, OOS, product disposition, QPs (as applicable), deviations and change records and ensuring each partner is receiving adequate Quality support & resources/ accountable for meeting "service level agreements"
• Identifying quality requirements on risk mitigation strategies, compliance/ technical issue resolution, and plans for continuous improvement / OE programs
• Resolving issues and escalating as appropriate
• Up to 40% travel (both domestic and international)
• Lead, develop, mentor and guide staffBasic Qualifications:
  • Advanced scientific degree (i.e. MD, PharmD, PhD) and 10+ years' experience in working within the biotechnology and/or pharmaceutical industries -in a Quality ownership role OR
  • Master's Degree and 12+ years' experience in working within the biotechnology and/or pharmaceutical industries -in a Quality ownership role OR
  • Bachelor's Degree and 14+ years' experience in working within the biotechnology and/or pharmaceutical industries -in a Quality ownership role OR
  • Associate Degree and 16+ years' experience in working within the biotechnology and/or pharmaceutical industries -in a Quality ownership role OR
  • High School Degree and 18+ years' experience in working within the biotechnology and/or pharmaceutical industries -in a Quality ownership rolePreferred Qualifications:
    • Bachelor's or higher degree with 10+ years of experience working within the biotechnology and/or pharmaceutical industries -in a Quality CMO ownership role
    • A quality operations leader, skilled at partnering and collaborating with external quality leaders and teams, specifically with contract development and manufacturing organizations (CMO/CDMO), and Contract Testing Labs (CTLs), and strategic business partnerships
    • Diplomacy skills and ability to supervise performance and proactively identify and mitigate risks
    • Experience in managing & collaborating in a cross-functional working model with support from fully- and partially dedicated resources
    • Knowledge & experience in working across various GXP settings
    • Exhibit guidance skills and strategic, network-based thinking
    • Experience with direct FDA interaction (or other regulatory agencies) required
    • Experience auditing CMOs/CTLs. -Experience with direct FDA interaction (or other regulatory agencies) required
    • Experience writing, evaluating and closing investigations, CAPAs and change control records. -
    • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
    • International partnership experience (e.g. CDMO, CTL and/or Strategic Partners)
    • Cultural sensitivity and understanding of regional & global perspectives / marketplace
    • Excellent data analytics skills e.g. Tableau, Excel
    • Excellent skills in Risk Assessments, FMEA and QbD
    • Budget and Financial Planning experience
    • Excellent decision-making skills in a meaningful environment
    • Excellent oral and written communication skills
    • Thorough interpersonal and people development skills, open minded to the diverse points of view of others and able to lead effectively through influence
    • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
    • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.#QCQA123#IND123#LI-ML1Kite 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 , Senior Director, External Quality, Executive , Santa Monica, California