- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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Quality Assurance Manager
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
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Pharmaceutical Quality Assurance Manager
2 weeks ago
Fladger Associates Foster City, United StatesResponsibilities: · - Excellent employment opportunity for a Senior Manager in a Parsippany, NJ (preferred) or Foster City, CA area. · - R&D Deviation and CAPA Management · - R&D Quality and Medical Governance · - Onsite - Tuesday/Wednesday/Thursday · - Build, deploy and reinforc ...
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Manager, Quality Assurance
10 hours ago
Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
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Quality Assurance Manager
2 weeks ago
Bayview Hunters Point Foundation for Community Imp San Francisco, United States**What We Do**: · Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. · Our mission is to build a community that is empower ...
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Quality Assurance Manager
2 weeks ago
Lumenous Device Technologies Santa Clara, United States**Lumenous is Hiring** · Lumenous Device Technologies is at the forefront of medical device manufacturing for ultraprecision medical components for interventional catheters, implants, robotic surgery, and a wide variety of components used in mínimally invasive medical devices thr ...
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Assurance, Audit Manager
1 week ago
MGO Walnut Creek, United StatesOverview: · At **MGO** we believe that human care comes first. Only when our talent thrives can they deliver their very best to our clients. We are honored to serve agents of change in culture-shaping industries - including cannabis, sports and entertainment, technology and state ...
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Product Manager, Age Assurance
2 weeks ago
TikTok San Jose, United StatesResponsibilities · TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, London, Paris, Berlin, Dubai, Singapore, Jakarta, Seoul and Tokyo. · Why Join Us · Crea ...
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Senior Manager, Quality Assurance
2 weeks ago
Gilead Sciences San Mateo, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Senior Manager, Quality Assurance
3 weeks ago
Gilead Sciences San Mateo, United StatesSenior Manager, Quality Assurance · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and inves ...
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Senior Quality Assurance Manager
1 week ago
Gilead Sciences San Mateo, United StatesResponsibilities: · Excellent employment opportunity for a Senior Manager in a Parsippany, NJ (preferred) or Foster City, CA area. · R&D Deviation and CAPA Management · R&D Quality and Medical Governance · Onsite - Tuesday/Wednesday/Thursday · Lead and facilitate Quality Eve ...
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Senior Manager, Quality Assurance
2 weeks ago
Gilead Sciences Foster City, United StatesJob Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
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Senior Quality Assurance Manager
2 weeks ago
Gilead Sciences Foster City, United StatesResponsibilities: · Excellent employment opportunity for a Senior Manager in a Parsippany, NJ (preferred) or Foster City, CA area. · R&D Deviation and CAPA Management · R&D Quality and Medical Governance · Onsite - Tuesday/Wednesday/Thursday · Lead and facilitate Quality Event In ...
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Manager, Quality Assurance
3 weeks ago
Natera San Carlos, United StatesPRIMARY RESPONSIBILITIES:Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions. Maintain an influential and effective network and communication with leadership team members for identifying quality impr ...
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Manager, Quality Assurance
2 weeks ago
Natera San Carlos, United StatesPRIMARY RESPONSIBILITIES: Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions. · Maintain an influential and effective network and communication with leadership team members for identifying quality ...
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Senior Manager, Quality Assurance
3 weeks ago
Gilead Sciences, Inc. Foster City, United States Paid WorkFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – wor ...
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Sr. Manager, Quality Assurance
5 days ago
Vaxcyte, Inc. San Carlos, United States Full timeJoin our Mission to Protect Humankind · Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to er ...
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Quality Systems Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.. Independently review, initiate, complete, and tho ...
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Quality Assurance Manager
3 weeks ago
Shaw Bakers South San Francisco, United StatesAbout Shaw Bakers · At Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggres ...
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Sr. Manager, Quality Assurance
4 days ago
Vaxcyte San Carlos, United StatesJoin our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradi ...
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Case Manager Ii, Acute
3 weeks ago
Sutter Health San Mateo, United States**Organization**: · MPHS-Mills-Peninsula Medical Center · **Position Overview**: · This position coordinates the utilization management, resource management, discharge planning, post-acute care referrals and care facilitation. This position oversees the management of acute patien ...
Quality Assurance Manager - San Mateo, United States - Actalent
Description
Description:
• Ensures site quality oversight of commercial and/or development products at CMO's.
• Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions.
• Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on development programs.
• Ensures that performance and quality of drug products conforms to established standards and regulatory requirements.
• Assure CMO's meet Gilead quality regulatory and compliance standards in order to ensure a sustainable delivery of quality product to patients and maintains a good working relationship.
• Reviews regulatory documents and provide expertise and guidance in interpreting governmental regulations agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections.
• Collaborates engages and works cross functionally with other Quality groups.
• Acts as an escalation contact for complex and high impact quality issues concerns and decisions.
• Leads/coordinates investigations and the development and implementation of corrective and preventative action (CAPA)
• Quality risk management identifying key risks impacting commercial and development programs
• Competent in execution and responsible for translating quality strategy into plans of actions
• Anticipates shifts in industry trends and regulatory environment that will impact Gilead's business needs and positions the functions to respond accordingly
• Participates in developing controlled documents (e.g. SOPs, validation etc.)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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