Associate Director R&D Quality Business Partners (GLP, GCLP)
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 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.
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R&D Quality and Medical Governance (Q&MG) is seeking an Associate Director, Functional Quality Business Partner (GLP/ GCLP) to join our high-performing team to support Research and Development functions at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for functional leaders responsible for the conduct and oversight of GLP and GCLP regulated activities. You will partner closely with business functions in applying a risk-based approach to key activities which include vendor oversight, process development, issue management and governance. You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations.POSITION OVERVIEW:
You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices (GxP). You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice on GxP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality and Medical Governance groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. You may lead special projects that advance the capabilities of multiple team members across R&D Quality Business Partners. You may be a standing member of the overall R&D Quality and Medical Governance Extended Leadership Team with responsibilities for helping build and shape capabilities, and short- and long-range infrastructure across the overall R&D Quality and Medical Governance organization.EXAMPLE RESPONSIBILITIES:
- Serves as the Functional Quality Business Partner lead for assigned Gilead R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
- Advance the understanding of Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP) in support of R&D programs and the regulatory framework to ensure data integrity and patient safety
- Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.
- Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
- Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on all internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
- Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings.
- Supports deviation identification, reporting, and CAPA development.
- Leads intra/inter-departmental teams that support operations (e.g., evaluation of new regulations and potential implications for Gilead R&D and/or R&D vendors).
- Gain insights from metrics and other mechanisms to uncover trends and/or gaps in laboratory quality and advise business on any mitigation steps
- Participate in or lead cross functional process quality improvement initiatives
- Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
- Collaborates with other R&D Quality and Medical Governance teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
- Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.U.S. Education & Experience
Rest of World Education & Experience
- PharmD/PhD with 2+ years' experience.
- MA/MS/MBA with 8+ years' relevant experience.
- BA/BS with 10+ years' relevant experience.
- Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
- Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
- Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in quality, compliance or a related field.Knowledge & Other Requirements
- Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and GxP compliance within the biopharma industry,
- Expert knowledge of GLP regulations and GCLP guidelines.
- Good understanding of CAP/ CLIA requirements.
- Minimum of 5 years GLP quality assurance unit (QAU) experience; Clinical bioanalytical QA experience is a plus.
- Sponsor experience in a quality role is highly preferred.
- Experience supporting the build of a GLP compliant QMS is a plus
- Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
- Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
- When needed, ability to travel.
The salary range for this position is: $172,890.00 - $223,740.00. 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*.
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 ApplicantAccommodations@gilead.com for assistance.
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