Director, Quality Systems
Director, Quality Systems
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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 Global Director for Quality Systems. This is a critical leadership role responsible for overseeing the strategic development implementation and maintenance of global quality systems and processes across our cell and gene therapy product manufacturing network. This role ensures the quality compliance and effectiveness of our operations through the management of key quality system elements including change control deviations corrective and preventative actions (CAPA) training and document control. The Director will provide technical expertise and strategic direction in quality systems to ensure robust and harmonized processes globally.
Job Responsibilities
Global Quality System Oversight:
Develop implement and manage comprehensive global quality systems and processes including change control deviation management CAPA training and document control.
Serves as the primary point of contact and decisionmaker for internal policies procedures and strategy documents governing core quality system elements across the global network.
Support in knowledge advancement beyond the Quality organization to build maintain and develop capabilities across the network for core quality system processes.
Develop knowledgebased programs to advance education and training programs related to these systems.
Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified.
Sponsor and oversee activities focused on driving process improvements and harmonization projects across the network for change control deviations CAPA training and document control.
Serve as the SME leadership role for topics associated with change control deviations CAPA training and document control across the network representing on network teams and other appropriate governance forums.
Provide technical support during new process design and facility startup activities to ensure quality system requirements are integrated at the sites.
Engage in providing support during regulatory submissions and onsite inspections related to quality systems.
GMP Compliance and Quality Control:
Ensure all quality system processes comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines (e.g. FDA EMA).
Provide guidance on developing and validating quality system processes and associated documentation.
Provide technical support for investigations related to deviations and CAPA to help identify root cause and implement effective corrective and preventative actions. Share best practices/learnings across the network.
Oversee the development and implementation of global training programs on quality system requirements.
Ensure the establishment and maintenance of a robust global document control system.
CrossFunctional Collaboration:
Provide technical expertise in quality systems to crossfunctional teams including Manufacturing Quality Assurance Process Development and Regulatory Affairs.
Participate in the development and improvement of manufacturing processes ensuring robust quality system controls are integrated.
Interact with regulatory agencies and provide quality system expertise during inspections.
Stay current with the latest advancements in quality systems management regulatory expectations and cell and gene therapy manufacturing.
Basic Qualifications:
PhD in a scientific discipline engineering or a related field with 8years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment OR
Masters degree in a scientific discipline engineering or a related field with 10years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment OR
Bachelors degree in scientific discipline engineering or a related field with 12years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment OR
Associates degree in scientific discipline engineering or a related field with 14years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment OR
High School Degree with 16 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment.
Preferred Qualifications:
Advanced degree in a scientific discipline engineering or a related field.
Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry with a significant focus on quality systems management in a sterile manufacturing and advanced therapies environment.
Experience with cell and gene therapy manufacturing processes and associated regulatory requirements.
Prior experience in a global role with responsibility for quality systems.
Experience with electronic quality management systems (eQMS).
Experience in leading and managing direct reports and crossfunctional teams.
Demonstrated ability to effectively collaborate with and influence stakeholders at all levels of the organization including senior leadership.
Extensive knowledge of cGMP regulations FDA/EMA guidelines and industry best practices related to quality systems in cell and gene therapy manufacturing.
Strong expertise in the principles and application of change control deviation management CAPA training program development and document control systems.
Proven experience in developing implementing and maintaining global quality systems.
Excellent leadership communication (written and verbal) and interpersonal skills.
Strong problemsolving analytical and risk assessment skills.
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.
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Required Experience:
Director
Employment Type
Full-Time
