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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting millions of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Senior Director, GVP Audits
The Senior Director of GVP Audits (GVP) is responsible for leading the R&D GVP/Pharmacovigilance Audit program and associated processes, ensuring its effectiveness and continuous improvement, while supporting a strong Quality System. This role supports the shaping of the global strategic direction of the Quality Audit program to assure compliance with regulatory requirements across Research & Development (R&D), as well as contributing to the broader vision and strategy of the Governance, Risk and Analytics (GR&A) Team.
The Senior Director’s responsibility includes leading a team of auditors, delivering an effective GVP annual plan, and ensuring seamless operations. The Senior Director’s success will be dependent on building strong and trusted partnership with the business and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with the Heads of GCP and eSystems Audits, as well as with various business areas (Global Patient Safety, QPPV, and PV Programs), lead strategic process improvement projects, support quality forums, and establish GVP operational measures to ensure the organization’s compliance and quality objectives are met.
This role is a valuable member of R&D Quality’s Governance, Risk & Analytics leadership team. GR&A is accountable for driving the integration and peak performance of R&D’s Quality Management System, across Clinical Development and Post-Marketing, supporting the quality of Gilead’s growing portfolio of life-changing medicines. GR&A represents key Quality System Elements and includes the Audit, Deviation, CAPA, Risk Management, Escalation/Serious Breach, and Quality Analytics/Data Science programs
PRIMARY RESPONSIBILITIES
GVP Audit Program Leadership:
Lead the GVP Audit program, ensure adherence to regulations and industry best practices, and maintain an external network to assure current understanding of industry trends.
Develop and maintain procedures, policies, and documentation specific to GVP Audit activities related to process, vendor, and affiliates.
Implement, monitor, and report GVP Audit performance measures at senior leadership meetings and oversight forums, including continuous improvement plans.
Provide oversight and direction for contractor auditors, including monitoring performance, tracking quality metrics, and ensuring adherence to established standards.
Support the program head with budget management for responsible areas, provide oversight and align with best practices.
Coach and mentor team members on effective GVP Audit management, problem-solving techniques, and collaborative engagement.
As the GVP program lead, this role will be responsible for the growth and development of the GVP Audit team and ensuring inclusion and equal voice.
Lead high risk/directed audits, as needed
GVP Audit Operations:
Drive the development of robust and appropriate audit execution plans and review/approve audit reports.
Implement and deliver an effective risk-based and data-driven strategic GVP Audit plan/schedule, in partnership with R&D Risk Management, work with business stakeholders on risk factors and data collection (including proper documentation, supporting procedures and effectiveness checks on risk model).
Establish and maintain a Governance framework for GVP Audit Service Providers (primary and secondary strategic partners). This includes qualification/re-qualification of partners and service providers (i.e., processes, procedures, and relevant documentation)
Manage/Support external partner GVP Audit activity, in collaboration with R&D Quality Business Partners
Monitor the effectiveness of GVP Audit program though analytics and stakeholder engagement.
Establish ongoing and periodic assessment of all audit activities, auditee feedback, and self- assessment of audit activities (i.e., building high performance standards).
Quality Management:
Interface with internal and external stakeholders, including presenting at appropriate engagements, building visibility into GVP Audit program and overall impact on QMS performance and business controls.
Responsible for the continued maturity of the GVP Audit program and effectiveness, including quarterly report to senior leadership through management reviews.
Be actively involved in regulatory inspections/review of responses impacting Global Patient Safety and Pharmacovigilance programs, as appropriate.
Stay informed of regulatory changes and industry trends affecting R&D quality management and GVP/Pharmacovigilance; Includes sharing trends/learnings through forums and internal channels.
Work closely with the R&D CAPA program, ensure timely completion of audit related CAPAs, post-reviews and lessons learned.
Establish an Effectiveness Check strategy, in partnership with GCP and eSystem Audit Heads for Audit related CAPAs.
Support investigation teams on quality issues/events investigations, as appropriate.
Training & Development:
In collaboration with GCP and eSystems Audits, provide support and management of audit training for R&D Quality staff. This includes working with line managers to develop staff competencies and capabilities in conduct of audits, report generation, response review and CAPA development.
Develop and deliver training and learning programs related to Audit processes and developing responses and effective audit CAPA plans, for R&D staff.
Collaborate with CAPA program to ensure effective integration and use of CAPA system and procedures.
Support the development and training of internal staff, including fostering a commitment to quality in individuals and a culture of quality within the organization.
BASIC QUALIFICATIONS
PhD degree with 12+ years of Pharmacovigilance, Auditing, and Quality Systems experience OR
MA / MS degree with 12+ years of Pharmacovigilance, Auditing, and Quality Systems experience OR
BS / BA degree with 14+ years of Pharmacovigilance, Auditing, and Quality Systems experience
PREFERRED QUALIFICATIONS
Advanced degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering).
Minimum of 14 years of experience in the biotechnology or pharmaceutical industry, with a focus on Pharmacovigilance, Auditing, and Quality Systems.
Expert knowledge of GVP requirements (FDA, EMA, ICH) and related industry standards and trends.
Expert level experience in scheduling, planning, execution and follow-up on Audits.
Proven track record in lean six sigma, total quality system and risk management execution.
Experience in leading investigations, root cause analysis, and CAPA implementation within R&D.
Excellent analytical, problem-solving, and decision-making skills.
Strong leadership and project management abilities.
Excellent communication and interpersonal skills.
Understands and operates on the values of prioritization and collaborative partnership and negotiation.
Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally
Extensive leadership experience and proven effectiveness, whether through direct people leadership or matrix leadership.
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
ABOUT R&D QUALITY
Gilead R&D Quality 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?
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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