Director, Quality MVP01

Descripción del trabajo

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We are looking for a Director of Quality for our Oceanside, CA location.

Responsibilities:

• Serves as a key business partner to senior stakeholders and the SLT focusing on strategic issues at the site and across multiple functions.
• Oversees the development and implementation of Quality program for RVV and LVV and/or across quality sub-functions.
• Monitors and ensures compliance with cGMP regulations. Establishes and publishes Key Performance Indicators to track GMP compliance across Quality functions.
• Chairs the Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
• Represent all Quality functions on the site leadership team.
• Quality Operations including lot disposition, audits and deviation management.
• Quality Systems including document management, change control, CAPA and Quality policy management.
• Lead Quality Control analytical, microbiological, and environmental monitoring, QC Tech services and laboratory management
• Inspection Management at the site conducted by US FDA and other regulatory health authorities.
• Develop and implement annual Quality plan for site, including site departmental goals, action plans and budgets
• Quality metric reporting to executive stakeholders through Management Review process
• Ensures that Quality systems and practices are developed, implemented and adhered to
• Interfaces with regulatory agencies as required, representing Kite to authorities and regulatory inspectorates. Supports preparations for and participates in regulatory authority inspections.
• Performs the QA review of externally and internally generated reports/documents as necessary.
• Develops an effective working relationship with all team members and external contractors.
• Supports/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA) recommendations related to distribution activities.
• Responsible for effectively developing and managing the budget.

Knowledge:

• Demonstrates in-depth understanding and application of GMP principles, concepts, best practices and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and philosophies.
• Demonstrates thorough knowledge of vector manufacturing processing and general pharmaceutical manufacturing.
• Ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist.
• Demonstrates extensive knowledge of industry best practices and trends.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Is comfortable interacting with regulatory agencies as needed
• Demonstrates experience and ability to manage staff.
• Is an experienced auditor with demonstrated acumen in resolving challenging audit situations.

Basic Qualifications:

• Doctorate and 8+ years of relevant experience OR
• Master’s and 10+ years of relevant experience OR
• Bachelor’s and 12+ years of relevant experience

Preferred Qualifications:

• Prior people management experience.
• Deep knowledge and experience in quality assurance, Quality Control, Regulatory compliance and Quality Engineering functions in a highly regulated manufacturing environment.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

Does this sound like you? If so, apply today!

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The salary range for this position is: $187,000.00 - $242,000.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite 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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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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 ApplicantAccommodations@gilead.com for assistance.

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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 Internal Career Site to apply for this job.