Vp, Quality Control Jobs

For Current Gilead Employees And Contractors

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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.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

VP, Quality Control

Key Responsibilities

The Vice President of Quality Control will develop, implement, and periodically evaluate a program to ensure the organizations production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization. This role will also provide oversight of our Laboratory Information Systems (LIS).

You Will

• Be responsible for translating quality strategy into plans of action.
• In collaboration with Analytical provide input to and assume overall ownership of all specifications and analytical methods for all products in all markets globally.
• Develop strategic goals for the LIS group including ensuring GxP guidelines and regulations are considered in system design to enhance the business application and support for regulatory inspections and internal audits.
• Serve as a key strategic partner to Gilead’s Manufacturing leadership team to develop business/operational plans across multiple functions/sites and be accountable for the implementation.
• Ensure world-class quality levels are established at the product design stage and quality system is focused on process control working in conjunction with lean manufacturing systems.
• Establish realistic quality goals and supporting tactics to achieve the company business plans.
• Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the function to respond accordingly
• Provides leadership and guidance on developing a strategic plan for the entire function - Uses extensive knowledge of all quality control sub functions areas and Gilead’s business strategies and goals to develop the functional strategic plan
• Develop data-driven and customer-focused capabilities that result in measurable improvements in product, process and supplier quality, customer support, responsiveness, and product reliability.
• Regularly interact with Gilead’s senior management and Quality Assurance on matters concerning quality.
• Partner with regulators, influence HA guidance and implement best practices across our global network of manufacturing sites, both internal and external including our network of QC laboratories.
• In partnership with QA, manufacturing and regulatory CMC, develop, implement, and sustain all quality systems. Champion and facilitate the use of LEAN/ Six Sigma, and other quality tools for quality and process improvement.
• Serve as a key business partner to senior manufacturing management teams focusing on strategic issues across multiple sites.
• Responsible for assuring that customer quality requirements have been adequately defined to permit appropriate quality planning and implementation and that the quality requirements have been met.
• Provide advice as sought by senior Quality Assurance, Control and Manufacturing leadership on key issues where guidance is relied upon to assess challenges and evaluate strategies.
• Provide leadership to direct reports and build a highly capable team through the attraction, training, and development of the necessary skilled professionals to meet business needs.
• Ensure multi-function continuity, alignment with company culture, and recognition of market practices, regulatory trends which foster a uniform Quality Control strategy
• Evaluate production operations from a strategic level to ensure that products meet quality, integrity,
• Drive efficient use of Quality resources, developing tooling and procedures for constant efficiency and improvements.

Requirements

• Prior success in working effectively with senior scientific and operations staff.
• Strong working knowledge of relevant regulatory guidance, including pharmaceutical GMPs (Good Manufacturing Practices) and ICH (International Council for Harmonization) guidance
• Experienced understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and solid knowledge of worldwide regulatory requirements
• Significant in-depth understanding of business objectives and how they translate into quality priorities.
• Ability to quickly establish credibility with diverse audiences and be perceived as a leader.
• Must be able to exercise judgment and independently
• Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.
• Possesses in-depth knowledge of industry best practices
• Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels.
• Experience establishing and/or enhancing development and commercial GxP quality infrastructure and systems compliant with U.S. and international requirements and a successful record of accomplishment managing U.S. and international pre- and post-approval inspections.
• Expertise and track record in managing quality in a large, global pharma company
• Experience overseeing product approval (NDA or BLA) essential, i.e., transition from product development to commercial quality systems and operations.
• Expert people and project management skills
• Competent in both strategy and execution
• Extensive knowledge of GMP, GCP and GLP including 21 CFR Part 11
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.

Qualifications

• Extensive knowledge and experience in quality in highly regulated manufacturing environments is required.
• Experience in biotech or pharmaceuticals industry required.
• An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.
• 20+ years of experience and a BS, or degree in related fields.
• Experience managing People Managers.

People Leader Accountabilities

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Gilead Core Values

• Excellence (Being Your Best)
• Integrity (Doing What’s Right)
• Teamwork (Working Together)
• Inclusion (Encouraging Diversity)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 [email protected] for assistance.

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 [email protected] for assistance.

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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

Please log onto your Internal Career Site to apply for this job.