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Associate Director, Vendor Performance Oversight - San Mateo, CA, United States - GILEAD Sciences
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader.
As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job DescriptionR&D Quality and Medical Governance (Q&MG) is seeking an Associate Director, Vendor Performance Oversight to join our high-performing team that supports Clinical Development & Post Marketing programs at Gilead.
In this role you will be responsible for acting as performance lead for assigned vendors and vendor categories.In this role you will participate in cross functional governance and ensure performance is measured and transparently shared, as well as partnering with internal and external shareholders to ensure effective responses to key issues and performance trends.
Within this role you will be part of the R&D Quality Business Partner network who are assigned to groups such as Gilead R&D functions or vendors supporting Gilead R&D.
Quality Business Partners provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices (GxP).
You will support the education of assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements.
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 risks or issues. You will participate in and/or lead governance forums, cross-functional teams and/or projects.You will collaborate with other R&D Quality and Medical Governance 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.
EXAMPLE RESPONSIBILITIES:
Serves as the Performance lead for assigned Vendors/ Vendor Categories, including but not limited to representing performance related matters at cross functional governance.
Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement.Develops and maintains Key performance Indicators for assigned vendors and categories by partnering with functions and vendors and utilizing industry best practices.
Supports stakeholders in escalated and/or high impact performance issues with vendorsDevelop Vendor Issue Plans as required to support resolution and CAPA responses for issuesHandles multiple projects simultaneously and ensures overall and timely completion of tasks.
Supports the evaluation, writing and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.Present Performance Data (e.g. KPI's, issue trending, etc.) at various Governance level meetings for high-medium risk vendorsCollaborates with other R&D Quality and Medical Governance teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation 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.
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/or performance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
Experience working across a broad spectrum of vendor space (e.g. CRO, clinical labs, technology), performance management and/or quality activities in a GCP settingSignificant 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 with GCP vendors, performance, 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).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.
The salary range for this position is:
$172, $223, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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
SummaryLocation:
United States - California - Foster City; United States - New Jersey - ParsippanyType: Full time
