Sr Director, R&D Quality & Medical Governance - Audit, Inspection & CAPA Management

Sr Director, R&D Quality & Medical Governance - Audit, Inspection & CAPA Management
United States - California - Foster CityUnited Kingdom - Cambridge

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?

R&D Quality and Medical Governance is seeking a Senior Director, Audit, Inspection and CAPA Management to join our Senior Leadership Team that oversees GCP, GLP and GVP activities at Gilead. In this role you will be responsible for providing global strategic direction and leadership for the audit, inspection and CAPA management programs across R&D. You will have accountability for each of these programs, assuring independent oversight and a strong voice of quality.

In addition to strong leadership skills, expert knowledge of the regulations governing drug development and post marketing activities as well as deep understanding of Quality Risk Management principles are key capabilities.

Key Responsibilities:

• Using a risk-based approach, develop Annual Master Audit Plan with contributions from other SLT members
• Execute against plan with the orchestration of internal auditors and external providers
• Establish a preferred external partner relationship to supplement auditor capabilities in GxPs and enable global presence to scale with the portfolio
• Identify trends from observations for robust mitigation
• Build auditor capabilities through learning and mentoring relationships
• Drive a constant state of inspection readiness
• Maintain inspection calendar assuring readiness for routine and unannounced inspections
• Drive creation of inspection management tools for consistent application across GxP inspection types
• Assure inspection flow and serve as front room or back room host when needed
• Assure robust responses to Health Authorities
• Hold organization accountable for timely completion of audit and inspection commitments
• Oversee CAPA management processes, supporting technologies and oversight programs to drive appropriate corrective actions and identification of trends
• Represent R&D Quality on due diligence exercises to identify Quality risks
• Develop GxP regulatory intelligence process to assure new requirements are understood and procedures developed to address
• Serve as an expert and provide guidance on and interpretation of global GCP/GCLP/GVP regulations, standards and quality systems for internal stakeholders
• Support overall Quality & Compliance goals and objectives including but not limited to resource budget and outputs, and line management oversight of the Quality & Compliance team
• Supervise, develop, train and manage internal staff. This includes fostering a commitment to quality in individuals and a culture of quality within the organization
• Leads intra or interdepartmental teams such as continuous improvement initiatives

Minimum Qualifications:

• Bachelor's degree with 12+ years; Master's degree with 10+ years; or PhD with 8+ years of R&D Quality Assurance Compliance experience in pharma
• Must have broad GCP/GCLP/GVP audit and compliance experience
• Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization
• Proven experience in managing vendor compliance programs
• Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2)
• Proven effective verbal, written, interpersonal skills to include delivering presentations to executives
• Recognized as an expert resource on a range of compliance topics
• Management of junior and senior staff
• Demonstrated effective verbal and written communication skills
• Proficient in Microsoft Office suite
• Excellent organizational and project management skills
• Able to lead and mentor effective cross functional teams.
• Ability to travel approximately 25%

Preferred Qualifications:

• Familiarity with GLP and 21 CFR Part 11 electronic systems and compliance activities
• Experience with Audit management/CAPA management programs

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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