Senior Director, Oncology Quality Lead, 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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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, Oncology Quality Lead to join our Quality Business Partners Leadership Team. In this role you will lead and set strategy for a global team that provides the GCP quality oversight for Oncology products in development at Gilead.
Acting as trusted business partners you and your team will work closely with R&D functions in applying expert GCP knowledge and a risk-based approach that enable decision making. You will also be a key member of the R&D Quality and Medical Governance Leadership Team advancing a culture of Quality across Gilead.
We seek an individual with strong leadership skills, expert therapeutic area knowledge, advanced understanding of the regulations governing drug development and the application of Quality Risk Management principles.
You will be a part of a dynamic global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.Primary Responsibilities
- Design and implement the Quality Strategy for the Oncology Therapeutic Area.
- Lead and direct assessment of Oncology risk areas and provide these insights to the Quality and Medical Governance Audit and Inspection Management programs in order to prioritize oversight activities and propose modifications where necessary.
- Help drive implementation of Quality by Design principles in Oncology development programs.
- Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and Clinical Data Sciences.
- Collaborate with Virology and Inflammation Quality Leads aligning on cross Therapeutic Area risks and the staff resourcing strategy.
- Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.
- Lead the analysis and interpretation of key quality data for the presentation and reporting to functional and executive leadership.
- Lead and supervise the management of critical and/or complex quality as well as the assessment of serious breaches for the Oncology TA.
- Lead Quality activities to support product submissions and responses to Health Authorities.
- Participate/provide expertise in in licensing and collaboration activities as applicable.
- Lead/oversee management of internal inspection readiness activities throughout program life cycle for Gilead study teams.
- Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
- Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
- Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
- Interface with key external Quality organizations for Gilead development partners and collaborations.
- Supports overall R&D Quality & Medical Governance goals and objectives including but not limited to resource budget and outputs, and line management oversight of the 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.
About Gilead R&D Quality and Medical Governance
- Bachelor's degree with 12+ years; Master's degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
- Must have broad GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.
- Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
- Proven experience in managing Oncology compliance programs required.
- Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2) required
- Experience leading business process improvement projects required.
- 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.
- Proficient in Microsoft Office suite.
- Experience with Inspection and Audit management/CAPA management programs strongly preferred.
- Excellent organizational and project management skills.
- Able to lead and mentor effective cross functional teams.
- Ability to travel approximately 20% required.
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.
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?
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