Associate Director

Associate Director, R&D Quality Business Partner
United States - California - Foster CityUnited States - New Jersey - ParsippanyUnited States - Washington - Seattle

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

For Current Gilead Employees and Contractors:

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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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

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. You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice specifically on GCLP 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 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. Where applicable, you will play a lead role in R&D vendor qualification, on-boarding, relationship management and governance. You may provide GCLP/GLP support for company integrations, as applicable.

EXAMPLE RESPONSIBILITIES:

• Serves as the 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.
• 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.
• Lead company integration related activities for GCLP/GLP and related vendors
• 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).
• 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 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.
• Provides matrix management and leadership to project teams.
• 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.

This position will be filled at the Associate Director or Senior Manager level, based on experience of the identified candidate.

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

• 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, pharmacovigilance or other drug development activities.
• Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.

Rest of World Education & Experience

BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant 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 compliance within the biopharma industry, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC). This specific role is looking for experience in GCLP/GLP regulations and vendors.
• 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: $177,905.00 - $230,230.00. 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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