Associate Director, R & D Quality and Compliance
Associate Director, R & D Quality and Compliance
United States - New Jersey - Morris PlainsUnited States - California - Foster CityUnited 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. Gileads 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 companys five core values. Thats 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
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. Headquartered in Foster City, California, Gilead has operations in North America, Europe, and Australia. We are committed to transforming the promise of science and technology into therapies that can make a meaningful difference in patients' lives. We are passionate about advancing treatments for - and potentially curing - some of the world's most challenging and complex illnesses and bringing these scientific innovations to people in need. Focus on areas of high unmet needs, including HIV, HBV, HCV, Oncology,
Inflammatory & Infectious diseases.
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 Compliance (Q&C) is seeking an Associate Director, Vendor Compliance & Risk Management (VCRM) to join our high-performing team that supports Clinical Development & Post Marketing programs at Gilead. In this role you will be responsible for providing compliance advice, direction, and leadership for quality and compliance oversight of GCP vendors. You will partner closely with business functions in applying a risk-based approach to key activities which include vendor qualification, audits, issue escalation and governance. You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations.
Our VCRM group within R&D Q&C 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 GCP & Clinical Operations vendor oversight and is highly visible and requires strong relationship building skills and the ability to influence and negotiate with cross-functional stakeholders. Professionalism and ability to represent Gilead's reputation externally is critically important. Auditing experience is required. An understanding of Quality Risk Management (QRM) principles, Phase 1 Clinical Research Units (CRUs), as well as a track record of leading process improvement projects is desirable.
You will be a part of an expert global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.
This role can be based out of our Morris Plains, NJ, Seattle, WA or Foster City, CA locations. We will also consider candidates who would be 100% remote.
- Oversees comprehensive vendor quality oversight program which includes vendor risk assessments, execution of the global audit strategy, Quality Issue Management for GCP vendors
- Tactically manages Audit Lifecycle (Planning, Coordination, Resourcing, Execution, & Reporting) for key GCP vendors including oversight of contract auditors for relevant vendor audit program.
- May lead or participate in vendor audits or internal process audits
- Leads compliance participation in vendor selection and governance activities.
- Interfaces with key internal business stakeholders and external groups including Vendors and Contract Research Organizations (CROs) and other Gilead and external Quality organizations.
- Serves as an expert and provide guidance on and interpretation of GCP regulations, standards, and quality systems for internal stakeholders
- Oversees effective vendor compliance reporting to functional management and the Gilead Senior Leadership team. This includes presenting relevant vendor metrics and trends in compliance risks at quality meeting & governance forums
- As an expert, provides 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 participates in Operational Management Team (OMT) meetings for key vendors.
- Reviews vendor contractual language from a quality & compliance perspective
- Supports management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management as needed.
- Leads intra or interdepartmental teams such as continuous improvement initiatives
- Supports overall R&D Quality & Compliance goals and objectives
- Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.
- Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organization.
- Bachelor's degree with 10+ years; Master's degree with 8+ years of R&D quality assurance compliance experience in a highly regulated environment.
- Must have GCP audit and compliance experience
- Proven experience in managing vendor compliance programs or supplier relationship management
- Has effectively operated within Clinical Quality Assurance in a Biopharma sponsor organization
- Experience with Audit management/CAPA management programs
- 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 compliance 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%
- Certification by ASQ (e.g. Certified Quality Auditor, etc.)
- Experience with Phase 1 Vendors / CRUs preferred
- Understanding of principles for Quality Risk Management (ICH Q9, ICH E6 R2) preferred
- Track record of leading process improvement projects (Lean Six Sigma Green/Black Belt preferred)
- Experience in developing and generating quality system metrics/trending
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?
The Gilead Difference
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:
- Integrity - Doing What's Right
- Inclusion - Encouraging Diversity
- Teamwork - Working Together
- Accountability - Taking Personal Responsibility
- Excellence - Being Your Best
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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