Gilead Sciences, Inc.
Director, Quality MVP01
Gilead Sciences, Inc., Oceanside, California, United States, 92058
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.Represents 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.Leads 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.Develops and implements 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 ORMaster’s and 10+ years of relevant experience ORBachelor’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 CFR Part 11/210/211).Does this sound like you? If so, apply today!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.
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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.Represents 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.Leads 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.Develops and implements 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 ORMaster’s and 10+ years of relevant experience ORBachelor’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 CFR Part 11/210/211).Does this sound like you? If so, apply today!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.
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