- Leads a team of auditors based in North America
- Demonstrated people leader experience (e.g. Workforce Planning, talent development, Budget adherence experience, promoting an inclusive and collaborative culture of trust and respect)
- Primarily conduct global vendor audits for contract manufacturing of Gilead Contract Manufacturers
- Support and/or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead's clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
- Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
- Align, strategize and collaborate with the Global Supplier Quality function within Gilead
- Enhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standards
- Represent the Quality function in by developing the program and supporting the selection process for new/preferred suppliers
- Act as liaison between global supplier quality and Gilead's production facilities
- Ensure CA/PA to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarks
- Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
- Work directly with Gilead cross-functional departments to gather key information and feedback prior to conducting vendor audits in order to ensure effectiveness.
- SAP Supplier and Material Master Data experience is a must (e.g. Creation, Maintenance, Governance)
- Participate in the development, implementation, and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process.
- Identify compliance risks and escalate issues to appropriate levels of management for resolution.
- Promote, awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified to better focus the scope of audits.
- Drive consistency with audit report observation writing, classification, status, and overall risk
- Conduct due diligence assessments as part of global expansion as required
- Identify and drive biologics audit program improvements and meet all required metrics and assigned goals
- Travel (Domestic and International) may be required up to 40%
Regulatory Intelligence - Effectively communicate regulatory trends, insights and implications for Gilead to senior leadership with presentations and written reports
- Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training
- Maintain online platforms (e.g., SharePoint) to provide intelligence related to Gilead's products, internal and external manufacturing and testing sites
- Design and author GMP RI newsletters to arm PDM staff with timely and actionable knowledge by aggregating and distilling information across multiple GMP subscription services, industry consortiums, and open meetings sponsored by health authorities
- Other responsibilities as required to meet business needs
Knowledge, Experience and Skills: - 12+ years of relevant experience and BS/BA degree; or 10+ years of relevant experience and a MS/MA or MBA degree.
- Extensive background in Biologics Operations (e.g. Supplier Management, Manufacturing, Quality Control, Quality Assurance)
- Demonstrates excellent verbal, written, and interpersonal skills.
- Demonstrates a thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
- Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, , 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO, PIC/S and USP/NF, EP, and JP compendial standards and principals as applicable.
- Skilled auditor with 10 years of experience and ability to perform investigative audits
- Demonstrated experience to manage staff.
- Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Biopharmaceutical or Pharmaceutical experience preferred.
- Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial
The salary range for this position is: $205, $266, Gilead 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*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE 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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
jeid-179f62d1e029044aa12d6b14d4939d38 -
Gilead Sciences Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · 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 dev ...
-
Director, Quality Assurance Compliance/Auditor
4 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 ...
-
Director, Quality Assurance Compliance/Auditor
3 weeks ago
AAPC San Mateo, CA, United StatesDirector, Quality Assurance Compliance/Auditor Job 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 improv ...
-
Compliance Auditor
3 weeks ago
Albertsons Co. Pleasanton, United States(Northern California Division) Primary responsibility includes auditing store compliance in all categories with Company policies on code dating and product rotation. Special focus will be placed on General Merchandise and Grocery categories. Auditors Auditor, Compliance, Audit, S ...
-
Compliance Auditor
3 weeks ago
Cesar Chavez Foundation San Francisco, United StatesSUMMARY: · The responsibilities of the Compliance Auditor include performing detailed audits of tenant files, the property, and site-level operations to determine compliance with program/project requirements of the applicable affordable housing programs. These programs include b ...
-
Compliance Auditor
3 weeks ago
Alamedaalliance Alameda, United StatesBrief Description · PRINCIPAL RESPONSIBILITIES · : · Under the general direction of the Supervisor, Health Plan Audits,this position is responsible for supporting the Alameda Alliance for Health's (AAH) Compliance Program, with an emphasis on external/delegate auditing activit ...
-
Compliance Auditor
3 weeks ago
Alameda Alliance Alameda, United StatesPRINCIPAL RESPONSIBILITIES · : · Under the general direction of the Supervisor, Health Plan Audits,this position is responsible for supporting the Alameda Alliance for Health's (AAH) Compliance Program, with an emphasis on external/delegate auditing activities. · Principal res ...
-
Compliance Auditor
2 weeks ago
Alameda Alliance Alameda, United StatesPRINCIPAL RESPONSIBILITIES: · Under the general direction of the Supervisor, Health Plan Audits,this position is responsible for supporting the Alameda Alliance for Health's (AAH) Compliance Program, with an emphasis on external/delegate auditing activities. · Principal responsi ...
-
EY San Francisco, United States**Auditor, Assurance, Japanese Business Services (Audit Services) (Manager) (Multiple Positions , Ernst & Young U.S. LLP, San Francisco, CA.** · Full time employment, Monday - Friday, 40 hours per week, 8:30 am - 5:30 pm. · **MINIMUM REQUIREMENTS**: · Bachelor's degree in Account ...
-
Compliance Auditor I
1 week ago
Stanford Health Care PALO ALTO, United States Full timeIf you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. · Day - 08 Hour (United States of America)This is a Stanford Health Care job. · A Brief Overview ...
-
Quality Assurance Auditor
1 week ago
Invitae San Francisco, United StatesInvitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their fami ...
-
Quality Assurance Auditor
2 weeks ago
Invitae San Francisco, United StatesInvitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their fami ...
-
Quality Assurance Auditor
1 week ago
Invitae San Francisco, United StatesInvitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their fami ...
-
Claims Compliance Auditor
4 days ago
Russell Tobin San Francisco, United StatesJob Description · Job DescriptionTitle: Claims Compliance Auditor · Start: ASAP · W2 Contract Duration: 6 months · Location: Remote · Hours per Week: Flexible for Part-Time or Full-Time; 20-40 hours/week · Pay Range: $75-95/hr · Skills required: · Significant healthcare claims e ...
-
Compliance Testing Auditor II
6 days ago
SPS West Valley City, United StatesJob Description · Summary:This position will provide assurance that SPS is in compliance with applicable laws and regulations required for mortgage servicing by preforming law based audits of the Company. Reviews will be completed monthly to provide a compliance overview of the ...
-
Quality Assurance Compliance Specialist
1 day ago
Harvey Nash Newark, United StatesPosition: Quality Assurance Compliance Specialist (Biotech/Pharma) · Location: Newark, CA (Hybrid) · Duration: 06-month contract, likely to extend · Client Industry: Biotech/Pharma · Pay Range: $75-80 per hour · Must Have: · Quality Assurance - GXP systems · BA/BS preferred years ...
-
Quality Assurance Compliance Specialist
1 day ago
Harvey Nash Newark, United StatesSpecialist Quality Systems and Compliance IV · Newark, CA (hybrid) · 6 month contractHybrid - 2 days onsite 3 days remote · 8AM-5PM shift · potential to extend - unlikely to convert to FTE · Quality Assurance - GXP systems - required · BA/BS preferred years of experience · Interv ...
-
Quality Assurance Compliance Specialist
1 day ago
Harvey Nash Newark, United StatesRole: Specialist Quality Systems and Compliance IV · Loc: Newark, CA (hybrid) · Duration: 6 months contract with possible extensions · SERVICES and DELIVERABLES: · In support of Client's Quality Systems and Compliance initiatives, Service Provider shall perform the Services ident ...
-
quality assurance supervisor/compliance
2 weeks ago
Jobot Santa Clara, CA, United StatesWe are looking for a Quality Manager to join our growing team · At our core, we excel in engineering, precision machining, and fabricating intricate components and assemblies that not only meet but surpass the most exacting requirements of our clients in Aerospace, Defense, Semic ...
-
District Compliance Auditor-CA
2 weeks ago
CVS Health San Jose, United StatesJob Description · . · Required Qualifications · .. · Preferred Qualifications · .. · Education · Verifiable High School diploma or GED is required. · Business Overview · Bring your heart to CVS Health · Every one of us at CVS Health shares a single, clear purpose: Bringing our he ...
Director, Quality Assurance Compliance/Auditor - Foster City, United States - Gilead Sciences, Inc.
Description
Director, Quality Assurance Compliance/AuditorUnited 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 investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
For 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 - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description
We are currently seeking an industry leader for a Director, Quality Assurance role, who will report to Executive Director, Supplier Quality Management and Audits, within the Global Quality Systems & Compliance department. The role is highly visible, offer tremendous growth potential, and requires technical acumen, strong leadership, and collaboration with cross-functional stakeholders across QA, Global Supply Chain, Manufacturing Operations and Technical Development.
Essential Duties and Job Functions:
