Job description
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Job Description
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.
We are currently seeking an industry leader for an Associate Director, Supplier Quality role, who will report to Director, Supplier Quality within the Global Quality Systems & Compliance department. This role is responsible for direct quality oversight of material suppliers and will serve as the Quality Lead for specific Supplier Category (e.g., Devices, Packaging, Excipients). The role is highly visible, offer tremendous growth potential, and requires technical acumen, strong leadership, and collaboration with cross-functional stakeholders across QA, Global Supply Chain, Manufacturing Operations and Technical Development.
Key responsibilities:
- Provide supplier quality oversight of material suppliers (e.g., media, chemicals & excipients, single use systems, primary & secondary packaging component, device) under a centralized SQM function
- Manage suppliers holistically by utilizing internal (e.g., deviation trends, OOS) and external signals (e.g., regulatory intelligence, external audits)
- Manage supplier change notifications or vendor-initiated changes
- Manage supplier investigations and corrective actions
- Manage completion of audit observation responses in a timely and effective manner
- Align and negotiate Quality Agreement terms with internal stakeholders and external partners
- Deploy quality risk management principles to ensure appropriate risk mitigation and control is exercised at the commodity/material level when approving supplier corrective actions
- Monitor and measure the effectiveness of suppliers and provide periodic updates to Senior Leadership
- Develop and implement processes for supplier management and material management lifecycles
- Manage master data in SAP for supplier information to ensure alignment globally
- Travel may be required up to 20%
- Other responsibilities as required to meet business needs
Job requirements:
- Experience with direct supplier oversight and proficiency at the commodity/material level
- Knowledge of filling operations, packaging operations and related issues
- Knowledge of incoming inspection processes including material inspection plans, certification of materials and AQLs
- Knowledge and working experience in some of the following areas:
- Syringes (glass breakage investigations/certifications, fractography)
- Needles (defect investigations, e.g., hooked, bent, and cracked needles)
- Vials (delamination issues, cracked vials, developing reinspection processes, understanding of manufacturing processes)
- Stoppers (knowledge of coring, particulate investigations)
- Devices (manual needle guard issue resolution, auto-injector issues, component manufacturing)
- FDA inspection presenter experience
- Working experience in managing strategic partners and relationships
- In addition to QA experience, background in process or technical development, or manufacturing
- Demonstrated leadership skills and ability to make critical decisions related to projects and tasks
- Experience with applying risk management principles while providing supplier quality oversight
- Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs
- Candidate must be self-driven and work well in a team, taking on different roles as needed
- Candidate must be able to prioritize tasks and drive toward solutions, while working in a fast-paced and changing environment
Education and experience:
- 8+ years of relevant experience in a GMP environment along with a bachelor’s degree in science/engineering, OR 6+ years of relevant experience and a master’s degree in science/engineering
- Prior people management experience
The salary range for this position is: $172,890.00 - $223,740.00. 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:
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.
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.
For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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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