Associate Director, QA Compliance Supplier Quality Management
Associate Director, QA Compliance Supplier Quality Management
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
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.
Associate Director, QA Compliance - Supplier Quality Management
We are currently seeking an industry leader for an Associate Director, QA Compliance, who will report to Director, Quality within the Global Quality Systems & Compliance department. This role is responsible for building a Supplier Quality Management program to enhance current practices by providing guidance and leadership across all phases of the supplier management lifecycle, and unifying cross-functional and cross-site efforts where appropriate. Successful candidate will have deep expertise in global supplier management, program and process development, and/or direct supplier oversight. A strong foundation in operations, outsourcing and/or vendor management is critical for success in this role. The role is highly visible and requires strong leadership and collaboration with cross-functional stakeholders.
- Support the creation and execution of a Supplier Quality Management program with a multi-year strategy and roadmap to meet regulatory expectations and business needs, while benchmarking with the industry
- Assess current procedures, practices and systems to identify potential gaps and deploy mitigation strategies
- Develop and implement risk-based supplier management process(es) for site selection, onboarding, monitoring and offboarding (decommissioning)
- Lead cross-site, cross-functional team to drive improvements, and socialize efforts to raise awareness and promote branding
- Support roll-out and use of electronic quality system (e.g. Veeva, SAP) for supplier management
- Monitor and measure the effectiveness of the Supplier Quality program, and provide periodic updates to Senior Leadership
- Respond to queries from internal stakeholders to support M&A and site integration activities, inspection readiness, internal audits, and/or regulatory submissions
- Manage and develop staff through a culture of inclusion and empowerment
- Support regulatory inspections as needed
- Other responsibilities as required to meet business needs
Knowledge, Experience & Skills:
- 10+ years of relevant experience in a GMP environment related field and a Bachelor's degree in science or related fields OR 8+ years of relevant experience and a MS.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior people management experience.
- Experience with all aspects of supplier management - from vendor selection, qualification, routine management, contract and Quality Agreement development, to performance management - both individually and/or at program level
- 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
- Excellent interpersonal skills including ability to effectively speak with courage and candor across organizational levels and functions
- Charismatic leader with strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders
- Able to maintain a balance between being strategic/big-picture thinker and taking deeper tactical dives as needed
- Experience in developing and generating quality system metrics/trending
- Excellent task and time management skills (e.g., project planning, prioritization)
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
Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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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@example.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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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.
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