Director, Vendor Quality Management R&D Quality and Medical Governance

Director, Vendor Quality Management R&D Quality and Medical Governance
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited 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 #CreatingPossible

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Job Description


Director, Vendor Quality Management - R&D Quality and Medical Governance

R&D Quality and Medical Governance (Q&MG) is seeking a Director, Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development & Post Marketing programs at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk based approach to key vendor activities which include vendor qualification/requalification, issue escalation and governance. You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations.

You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions and 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 integrity and analytics, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead Quality role in R&D vendor qualification, selection, on-boarding, relationship management and governance.

Our VQM group within Q&MG needs someone with strong leadership skills, expert knowledge of the regulations governing drug development as well as deep vendor compliance & oversight experience. This role will focus on vendor oversight activities, is highly visible, requires strong relationship building skills and the ability to influence and negotiate with cross-functional stakeholders. Professionalism and the ability to represent Gilead's reputation externally is critically important. An understanding of Quality Risk Management (QRM) principles, experience managing people, as well as a track record of leading complex, cross functional process improvement projects is desirable.

You will be a part of an expert global Quality team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Primary Responsibilities

Oversees comprehensive vendor quality oversight program which includes vendor risk assessments, Quality Issue Management and governance for GxP vendors

Leads quality participation in vendor qualification, selection, requalification and governance activities.

Lead and support development and ongoing management of Quality Agreements with key vendors

Interfaces with key internal business stakeholders and external groups including Vendors and

Contract Research Organizations (CROs) Quality organizations.

Develops strong relationships with Gilead's key vendors, creating a mindset of partnership and

mutual respect

Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical

Governance on internal quality audits, regulatory agency inspections, risk assessments, deviations and CAPAs for vendor related activities.

Serves as an expert and provide guidance on and interpretation of GxP regulations, standards, and quality systems for internal stakeholders

Assists in inspection readiness and preparation, and/or directly supports regulatory agency

inspection. Assists in coordination of responses to any findings, as applicable.

Supports deviation identification, reporting, and CAPA development, as applicable.

Oversees effective vendor quality reporting to functional management and the Gilead Senior

Leadership team. This includes presenting relevant vendor metrics, trends and quality risks at quality

meetings & governance forums

As an expert, provide sound judgment and risk-based rationale to facilitate decision-making and

support the development and execution of effective and comprehensive action plans to address

quality and compliance risks.

Leads Quality-to-Quality (Q2Q) governance meetings and represents R&D Q&MG in Operational

Management Team (OMT) meetings for key vendors.

Reviews vendor contractual language from a quality & compliance perspective

Leads intra or interdepartmental teams as assigned, such as continuous improvement initiatives

May be a standing member of the Q&MG Extended Leadership team, with responsibilities for helping

build and shape capabilities and short-and long-range infrastructure.

Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.

May have one or more direct reports; Supervise, develop and manage internal staff.

May participate in and play an active role in R&DQ Q&MG short and long range budget and resource

plan development and management

Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with

R&D vendors.

Qualifications

Bachelor's degree with 12+ years; Master's degree with 10+ years of R&D quality assurance compliance experience in a highly regulated environment.

Must have GCP/GCLP/GVP audit and compliance experience

Proven experience in managing vendor quality programs and/or vendor relationship management

Has effectively operated within Clinical Quality Assurance or similar function in a Biopharma sponsor

organization

Extensive experience advising business functions in the biopharma industry on quality and compliance

Charismatic leader with strong relationship building skills, and ability to influence and negotiate with

cross-functional stakeholders

Effective verbal, written, interpersonal skills to include delivering presentations to executives

Recognized as an expert resource on a range of quality topics

Demonstrates leadership skills while working in fast-paced and changing environment

Strong organizational & project management skills including the ability to prioritize and adapt to

business needs while upholding compliance with regulations and company procedures.

Able to maintain a balance between being strategic and taking deeper tactical dives as needed

Excellent task and time management skills (e.g., project planning, prioritization)

Ability to travel up to 20%

Preferred

Understanding of principles for Quality Risk Management (ICH Q9, ICH E6 R2)

Track record of successfully leading complex, large scale, time sensitive projects

Experience in developing KQIs and monitoring for compliance and trends

Experience with the Veeva Quality modules

About Gilead R&D Quality and Medical Governance

Gilead R&D Quality and Medical Governance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

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 careers@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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