Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support
Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support
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$ 191250 - 247500
1 Vacancy
Job Description
Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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 seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role is a critical leadership role responsible for establishing implementing and maintaining global quality standards and processes for all company facilities and equipment. Serving as the primary point of contact and decisionmaker for internal policies procedures and strategy documents governing the quality of facilities and equipment across the global network this role will ensure robust and compliant infrastructure and assets. The Director will support knowledge advancement across the organization drive process improvements and harmonization represent the company in relevant industry forums and partner with global quality functions to ensure consistent and highquality standards.
Strategic Quality Oversight of Facilities and Equipment:
Serve as the primary global point of contact and decisionmaker for internal policies procedures and strategies governing facilities and equipment quality oversight.
Provide strategic quality oversight for the design installation commissioning qualification and validation of facilities equipment and utilities leveraging engineering standards Quality by Design principles and experience aligned with FDA ICH & ISPE guidelines.
Ensure all activities comply with current Good Manufacturing Practices (cGMPs) company policies and regulatory requirements.
Sponsor and oversee process improvements and harmonization projects across the network for facilities and equipment quality.
Ensure robust and consistent control strategies for facilities and equipment are maintained for valuation and continuous improvement meeting regulatory and compliance expectations.
Serve as the SME leader for facilities and equipment quality across the network representing on relevant teams and governance forums.
Provide technical support during new process design and facility startup to ensure site facilities and equipment quality programs and product requirements are met.
Provide technical support for investigations related to facilities and equipment quality to identify root causes and implement corrective actions sharing best practices/learnings/CAPAs across the network.
Support regulatory submissions and onsite inspections related to facilities and equipment; define and execute the process for managing network observations and commitments.
Technical Knowledge:
Demonstrate indepth understanding and application of GMP principles concepts best practices and standards (US and international) specific to facilities and equipment.
Ability to develop and improve complex concepts techniques standards and new applications for facilities and equipment based on quality principles.
Ability to develop innovative solutions to complex facilities and equipment quality problems where precedents may not exist.
Proficiency in data analysis of facility and equipment performance prioritization attention to detail critical decisionmaking and complex problemsolving.
Demonstrate extensive knowledge of industry best practices and trends in facilities and equipment quality and reliability.
Experience building effective working relationships across all internal and external stakeholders impacting facilities and equipment quality.
Demonstrate excellent verbal written and interpersonal communication skills.
Comfortable interacting with regulatory agencies on facilities and equipment topics.
CrossFunctional Collaboration:
Partner with Global Quality to support the development implementation and oversight of facilities and equipment quality programs.
Ensure local and global quality decisions related to facilities and equipment are applicable documented and traceable to company processes.
Support knowledge advancement beyond Quality to build and maintain capabilities across the network for facilities and equipment quality; develop knowledgebased programs and mentor stakeholder SMEs.
Collaborate globally with engineering facilities manufacturing and other departments to ensure quality requirements are met and business objectives achieved.
Communicate effectively with senior management and stakeholders at all levels.
Provide leadership guidance and support to team members fostering a culture of quality and compliance.
Basic Qualifications:
PhD with 8years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
Masters degree with 10years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
Bachelors degree with 12years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
Associates degree with 14years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment OR
High School Degree with 16 years of relevant experience in facilities management engineering quality assurance or a related field within a regulated environment.
Preferred Qualifications:
Demonstrated understanding and relevant experience of scientific and engineering principles for the design maintenance and quality oversight of facilities and equipment in a regulated manufacturing environment.
Experience in validation of facilities utilities and equipment.
Significant experience leading global teams and/or projects/initiatives related to facilities and equipment quality.
Experience with reliability engineering principles applied to pharmaceutical or similar manufacturing equipment.
Experience with cell and gene therapy manufacturing and associated facility and equipment requirements.
Indepth knowledge of specific regulations for cell and gene therapy facilities and equipment.
Certification in a relevant area (e.g. CQE CQA).
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 systems 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 jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Director
Employment Type
Full-Time
