Gilead Sciences
Quality Site Lead (Sr. Manager) - Foster City
Gilead Sciences, San Francisco, California, United States, 94199
Quality Site Lead (Sr. Manager) - Foster City
Gilead Sciences is seeking a Quality Site Lead (QSL) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of Biologics intermediates, drug substances and drug products for clinical and commercial distribution. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Job Functions
Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Gilead CXO partners/sites. Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key representative on Product Quality Teams for assigned CXO. Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Facilitates quality events for CXOs. Partner with internal stakeholders to identify solutions and processes and align with key partners on implementation of new requirements. Lead escalations for critical quality issues. Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings. Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements. Ensure GMP documentation is accurate and compliant with internal and external standards and requirements. Knowledge, Experience And Skills
Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Excellent verbal, written, and interpersonal communication skills. Basic Qualifications
8+ years of relevant experience and a bachelor’s degree in science or related fields; or 6+ years of relevant experience and an advanced science degree. Knowledge in technical and regulatory requirements pertaining to manufacturing, product lifecycle management, and outsourced operations a must. Biopharmaceutical or Pharmaceutical experience a must. Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must. 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.
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Gilead Sciences is seeking a Quality Site Lead (QSL) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of Biologics intermediates, drug substances and drug products for clinical and commercial distribution. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Job Functions
Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Gilead CXO partners/sites. Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key representative on Product Quality Teams for assigned CXO. Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Facilitates quality events for CXOs. Partner with internal stakeholders to identify solutions and processes and align with key partners on implementation of new requirements. Lead escalations for critical quality issues. Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings. Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements. Ensure GMP documentation is accurate and compliant with internal and external standards and requirements. Knowledge, Experience And Skills
Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Excellent verbal, written, and interpersonal communication skills. Basic Qualifications
8+ years of relevant experience and a bachelor’s degree in science or related fields; or 6+ years of relevant experience and an advanced science degree. Knowledge in technical and regulatory requirements pertaining to manufacturing, product lifecycle management, and outsourced operations a must. Biopharmaceutical or Pharmaceutical experience a must. Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must. 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.
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