Director, Medical Affairs Compliance, R&D Quality and Compliance
Director, Medical Affairs Compliance, R&D Quality and Compliance
United States - California - Foster City
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
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 Medical Affairs Quality and Compliance Director who is ready to support our Medical Affairs department. You will work with our Medical Affairs teams, and other functional areas as necessary, around the globe to provide support for compliance with the post marketing regulated activities they undertake, including but not limited to the following: non-interventional and real world evidence clinical research, medical information service, support for implementation of local labelling and management of risk minimization materials.
You will also work closely with teammates across R&D Quality and Compliance and other quality groups responsible for quality oversight of Medical Affairs.
We need someone with strong leadership skills, expert knowledge of Medical Affairs post marketing requirements, preferably experience with pharmacovigilance as well as late phase clinical research, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. You will be a part of an expert and supportive team that fosters constructive collaboration in support of our Medical Affairs post marketing activity.
- Lead and/or coordinate Medical Affairs compliance activities. Handle multiple projects and ensure overall and timely completion of tasks.
- Works closely with compliance staff and Medical Affairs to provide expert compliance information, manage identified issues, and support continuous improvement.
- Responsible for ensuring the development of audit plans and ensuring timely execution of plans for assigned programs. Collaborate and provide input into other audit programs (including affiliate and vendors) which support Medical Affairs compliance.
- Oversees routine and complex internal audits.
- Support deviation identification, reporting, and CAPA development
- Supervise, develop, train and manage internal staff as required.
- Ensure oversight of contract auditors.
- Undertakes effective compliance reporting to Quality and Compliance senior management and cross functional leadership
- Leads Medical Affairs quality governance forum and provides input to other quality forums as required.
- Leads intra/inter-departmental teams and/or projects that support preparing the Company for minor changes in regulations and continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
- Represent Quality and Compliance in cross functional Working Groups as required
- May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
- Fosters a commitment to quality in individuals and a culture of quality within the organization.
- 10-12+ years of relevant experience and a Bachelor's degree in a relevant discipline.
- 10+ years of relevant experience and a Master's degree, or equivalent, in a relevant discipline.
- 8+ years of relevant experience and a PhD or equivalent
- Must have significant Medical Affairs compliance support experience. Direct experience supporting PV and GCP activities preferred.
- Bio-pharma sponsor or CRO experience required.
- Recognized as an expert resource on a range of 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% 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 firstname.lastname@example.org 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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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