Director, Quality & Compliance (Q&C) Head, Global Inspection Management (GCP and GVP)

Location
Foster City, CA, United States
Posted
Apr 28, 2021
Ref
2238309
Required Education
Bachelors Degree
Position Type
Full time
Director, Quality & Compliance (Q&C) Head, Global Inspection Management (GCP and GVP)
United States - California - Foster CityIreland - DublinUnited Kingdom - CambridgeUnited 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

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

We are looking for a Director, Global Inspection Management who is ready join our R&D Quality and Compliance team.

As a member of the Q&C global management team you will provide leadership in setting the strategic direction and providing oversight for Gilead's GCP and PV inspection life cycle. Through strong collaboration and partnering you will be instrumental in facilitating a culture of readiness across the Gilead organization.

This role is suited to candidates who possess strong leadership and communication skills, strategic thinking ability and proven success in a matrixed organization. Utilizing expert Good Clinical Practice (GCP) and Good Pharmacovigilance (GVP) knowledge this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. You will be a part of an expert Q&C team supporting global clinical development and post-marketing programs.

Primary Responsibilities
  • Set global strategy and provide planning, preparation and conduct for GCP and GPV inspections of Gilead by global regulatory health authorities. This includes but is not limited to Gilead global development locations, Affiliates and clinical investigator sites.
  • Provide a point of contact for any of Gilead's partners and/ or vendors during their regulatory inspections that may involve Gilead studies and products.
  • Deliver planning for end to end inspection readiness activities, inspection management training, and developing and maintaining Gilead's inspection management process. Development of inspection management tools, including maintenance of Gilead inspection portal and systems.
  • Communication of inspection information to relevant Gilead leadership and functional areas including inspection announcements, daily updates and outcomes. This may also include general communication for Good Distribution Practices (GDP) inspections.
  • Leadership, direction and management of Q&C staff supporting regulatory inspection activities. This includes working with line managers to develop staff competencies and capabilities in the assessment of inspection readiness gaps, inspection conduct and CAPA development for inspectional findings.
  • Mobilization of subject matter experts to assist investigating and resolving inspection readiness gaps prior, during, and post inspection. This includes the development and provision of training and coaching of functional SME's for Inspections.
  • Oversee preparation of inspection risk assessments for senior management and key stakeholders so they are apprised key risks prior to an inspection and that appropriate corrective action plans are implemented in a timely manner.
  • Oversee strategy for support of Gilead Partner and Vendor inspections.
  • Application of advanced knowledge of regulations and regulatory inspection trends to ensure the functional areas within R&D are knowledgeable of regulations and can implement appropriate procedures to proactively manages and mitigates risks to achieve quality outcomes.
  • Owner of QMS policies and processes associated with Inspection Readiness and promotes excellence and continuous improvement associated with inspection readiness best practice and processes.
  • Management of all inspection related tools, documents and processes to ensure consistent global performance and continuous improvement.
  • Analysis of inspection data and metric development for effective compliance reporting to senior management and relevant quality governance forums.
  • Ensure that learnings from significant Regulatory Inspections are shared across the Gilead organization.
  • Maintain knowledge of regulatory inspection intelligence and participate in industry inspection forums.
  • Support CAPA development and perform effectiveness checks of CAPAs for inspection findings.
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Provides expert, timely and risk-based guidance in line with regulations & business needs.
  • Evaluate relevant departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements.
  • Lead intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.
  • Recruit and manage staff as needed.


Qualifications
  • BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
  • Must have significant GVP & GCP inspection experience, including hosting inspections for US FDA and international health authorities (EMA, MHRA, PMDA, MFDS, etc.).
  • Experienced people manager.
  • Bio-pharma sponsor experience required.
  • Recognized as an expert resource on a range of clinical compliance topics.
  • Strong verbal and written communication skills and interpersonal skills.
  • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
  • Excellent organization skills and project management.
  • Able to work equally well as part of a team or independently
  • Ability to travel approximately 25-30% required.


About Gilead R&D Quality and Compliance

Gilead R&D Quality and Compliance 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 and Compliance 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.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
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.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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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:
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