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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
Job Description
You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices. You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice specifically on GCLP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead role in R&D vendor qualification, on-boarding, relationship management and governance. You may provide GCLP/GLP support for company integrations, as applicable.
EXAMPLE RESPONSIBILITIES:
Serves as the Quality Business Partner lead for assigned Gilead R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.
Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on all internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings.
Supports deviation identification, reporting, and CAPA development.
Lead company integration related activities for GCLP/GLP and related vendors
Leads intra/inter-departmental teams that support operations (e.g., evaluation of new regulations and potential implications for Gilead R&D and/or R&D vendors).
Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
Provides matrix management and leadership to project teams.
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
This position will be filled at the Associate Director or Senior Manager level, based on experience of the identified candidate.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
PharmD/PhD with 2+ years’ experience.
MA/MS/MBA with 8+ years’ relevant experience.
BA/BS with 10+ years’ relevant experience.
Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials, pharmacovigilance or other drug development activities.
Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant experience working in quality, compliance or a related field.
Knowledge & Other Requirements
Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma industry, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC). This specific role is looking for experience in GCLP/GLP regulations and vendors.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
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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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 ApplicantAccommodations@gilead.com for assistance.
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