Associate Director, Quality Systems

Associate Director, Quality Systems
United States - California - Foster City

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. Gileads 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 companys five core values. Thats 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 #CreatingPossible

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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 hundreds of thousands 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.

Job Overview:

The Associate Director, GQSC, Quality Systems will report to the Director, GQSC Quality Systems and will be responsible for managing a team of quality professionals that ensure quality & compliance for GMP computerized systems globally at Gilead.

Job Responsibilities:

• Provides compliance guidance and quality oversight to project teams implementing electronic systems in a variety of regulatory environments.
• Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organization.
• Work closely with the Business Process Owners and IT to ensure deployment of GxP systems meets company standards, relevant regulations, such as 21 CFR Part 11 and Annex 11, and that systems are maintained in a validated state.
• Review and approval of computer system validation deliverables.
• Provide training on validation and electronic system compliance related topics to colleagues across the globe.
• Supervises the prioritization and coordination of the work of staff and/or consultants.
• Ensures annual audit plans are developed and audit activities are completed according to plan across sites.
• Provides guidance and leadership to junior staff also involved in regulated electronic systems implementation projects.
• Participate in the qualification of vendors and conducting ongoing audits utilizing a risk-based approach.
• Participate in internal process and systems audits.
• Assist in inspection readiness preparation, management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
• Maintain up-to-date on changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions, so the company is prepared to respond to such changes.
• Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.
• Assist in inspection readiness preparation, management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
• May act as a change agent on projects which have strategic impact on the organization.
• Represent Global Quality Systems & Compliance in internal and external meetings.
• Contributes to establishing compliance quality standards.
• Determines most efficient and appropriate method of communication in a variety of situations.
• Understands impact of decisions and actions on business and consults with appropriate colleagues and management.
• Promotes and maintains productive working relationships with staff and functional areas.
• Addresses sensitive issues in an objective manner.

Basic Qualifications:

Knowledge, Experience and Skills:

• 10+years of relevant experience in a GxP regulated environment and a Bachelor's degree in science or related fields. OR 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
• Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Significant experience with implementing and validating regulated systems (COTS, Saas, Bespoke) required.
• In-depth knowledge of GAMP 5 and software development lifecycle methodologies, testing best practices and computer software assurance.
• Extensive understanding of 21 CFR Part 11, Annex 11, and Data Integrity requirements.
• Experience with SAP ERP, Serialization, PLM and / or MES systems preferred
• Strong project management skills with the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures.
• Excellent written and verbal interpersonal communication skills.
• Experience to develop, mentor and manage a team of quality professionals.
• Ability to travel up to 20%.

Essential:

• Experience with risk management, quality agreements, and supplier relationship management
• Prior role or experience serving as a key leader to support organizational decision making or strategic planning
• Demonstrates leadership skills while working in fast-paced and changing environment
• Demonstrates ability to make critical decisions related to projects and tasks
• Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs
• Demonstrates thorough knowledge of compliance requirements and understanding of current global and regional trends
• Ability to operate with incomplete information

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

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.\u200b

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

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Director--Quality-Systems_R0022838

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