Exec. Director Quality Policy & Advocacy
United States - District of Columbia - Washington
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. Gilead’s 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 company’s five core values. That’s 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 #CreatingPossibleFor 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. Executive Director -Quality Policy & Advocacy, Washington DCKEY RESPONSIBILITIES
The Head of Quality Policy and Advocacy assures supply of quality medicines to patients by championing GMP compliance sustainability across the Gilead network and delivering on GMP regulatory strategies for successful pipeline launch and market access. The Quality Policy and Advocacy function partners with CMC Regulatory Affairs to protect and strengthen Gilead's "right to operate" and engages externally to foster Health Authority confidence and strategic industry collaboration. JOB DESCRIPTION
- Drive one interpretation of regulatory policy to enable consistent risk tolerance and provide a single source of truth for PQS implementation.
- Advance internal compliance by shifting information flow to a collaborative discussion.
- Strengthen Gilead's position for external advocacy and influencing through increased engagement with Gilead SMEs to enable effective and efficient delivery of Gilead's product portfolio to our patients.
- Leverage data analytics to eliminate waste from internal misalignment of policy implementation and revisiting of policy interpretation.
- Develop and lead advocacy topics, related working groups, and external interactions.
- Ensure “right-to-operate” by guiding self-empowered matrix teams toward a customer- orientated, lean, end-to-end mindset.
- Provides leadership to direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs for scientific advice, advocacy and intelligence with respect to Good Manufacturing and Distribution practices.
- Ensure matrix teams have the required proficiency to execute work packages, deliver their objectives, and seek ways of continuously improving.
- Advance the behavioral capabilities of the Network, by coaching matrix team members in new-ways-of-working approaches such as flow-to-work.
- Partner and build relationships with Leads to align on strategic priorities, accelerate decision-making, ease bottlenecks, and to support each other.
- Act as a strategic partner to stakeholders in Technical Development and Manufacturing Operations in support of organizational priorities.
- Develop annual budget, revising forecasts to meet business needs and monitor/ control expenditures to ensure efficient use of company resources.
- Help the Area Enabling Team's implementation of the Portfolio strategy, ensuring it is aligned with Gilead priorities.
- Monitor industry trends, keep up to date with regulatory requirements, and participate in company external influencing efforts.
- Help the Area Enabling Team meet the demands of today, and drive preparation for the future in terms of skills, capabilities and technologies.
- Boldly advance diversity, equity, and inclusion so that people feel safe to learn, to experiment, to challenge, to contribute autonomously — and safe to be themselves.
- A degree in life sciences, pharmacy, or related scientific discipline with directly relevant professional experience in highly regulated industries (such as pharma/biopharmaceutical or medical devices) of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD - including at least seven years of experience working in Quality, Compliance, Regulatory, and/or Validation.
Gilead Core Values
- A strong understanding of quality assurance concepts, such as Good Manufacturing Practices (cGMP) & GSDP Good Storage & Distribution Practices, and GCP knowledge.
- Direct experience working with a health authority (such as FDA, EMA) championing and enforcing GMP compliance in industry.
- Evidence of your ability to develop employees through their lateral and/or promotional movement internally or externally.
- Demonstrated experience in leading teams in a matrix environment.
- Experience in multiple manufacturing technologies and product lifecycles is desirable.
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- 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@example.com
The salary range for this position is: $242,590.00 - $313,940.00. 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.
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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 firstname.lastname@example.org
For more information about equal employment opportunity protections, please view the 'Know Your Rights'
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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:
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