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Senior Director, Vendor Quality

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Jun 26, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details


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, Vendor Quality to join our Quality Business Partners Leadership Team. In this role you will lead a team that provides the GCP, GLP and GVP Quality framework for quality oversight of Gilead vendors across R&D activities. Providing global strategic direction and leadership, your team will partner closely with R&D functions in applying a risk-based approach to key activities which include vendor qualification, audit planning, issue escalation and governance. 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 knowledge of the regulations governing drug development and post marketing activities as well as deep understanding of Vendor Quality Management principles.

You will be a part of an expert global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Primary Responsibilities

Build and maintain a comprehensive vendor quality management program which includes vendor risk assessments, risk-based audit planning, Quality oversight and issue management for all Good Clinical Practice (GCP), Pharmacovigilance (PV) & Laboratory vendors contracted by applicable departments. Oversee execution of Vendor Quality Agreements with vendors in partnership with the business, Legal and procurement functions. Establish vendor Quality metrics and analytics to enable oversight and reporting to functional management and Gilead leadership. Facilitate relevant governance forums 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. Serve as an expert and provide guidance on and interpretation of global GCP/GCLP/GVP regulations, standards and quality systems related to vendor quality management for internal stakeholders Interface with key internal business stakeholders and external groups including Vendors and Contract Research Organizations (CROs); other Gilead; and external Quality organizations. 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. Lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management as needed. Leads intra or interdepartmental teams such as continuous improvement initiatives.

Qualifications
  • 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/GCLP/GVP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.
  • Familiarity with GLP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
  • Proven experience in managing vendor compliance programs required.
  • Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2) required
  • Experience leading business process improvement projects required. Lean Six Sigma Green/Black Belt preferred.
  • 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.
  • Demonstrated effective verbal and written communication skills.
  • Proficient in Microsoft Office suite.
  • Experience with 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.


About Gilead R&D Quality and Medical Governance

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?

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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:

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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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