Manager, QA Compliance GMP Regulatory Intelligence

Location
Foster City, CA
Posted
Jul 24, 2021
Ref
2383915
Required Education
Bachelors Degree
Position Type
Full time
Manager, QA Compliance GMP Regulatory Intelligence
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. 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 #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.

Role and Responsibilities:

The Manager, QA Compliance will report to Director, Quality within the Global Quality Systems & Compliance department. This role will be primarily responsible for the development and implementation of a Regulatory Intelligence (RI) program for PDM to maintain GMP state of control. This role involves analysis and communication of key insights and implications of the changing regulatory landscape to senior leadership and business partners. The role is highly visible and requires strong leadership and collaboration with cross-functional stakeholders.

  • Define RI priorities and roadmap to proactively address regulatory challenges and business needs in collaboration with cross-functional partners
  • Support cross-site, cross-functional socialization effort for the RI program to raise awareness and promote branding
  • Develop and implement a sustainable process for collecting, evaluating and adopting regulations and guidance based on data, science and risk management principles
  • Design and author GMP RI newsletters to arm PDM staff with timely and actionable knowledge by aggregating and distilling information across multiple GMP subscription services, industry consortiums, and open meetings sponsored by health authorities
  • Effectively support communication of regulatory trends, insights and implications for Gilead to senior leadership with presentations and written reports
  • Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training
  • Develop and maintain online platforms (e.g. Tableau, SharePoint) to provide real-time intelligence related to Gilead's products, internal and external manufacturing and testing sites
  • Leverage data analytics to improve existing RI tools and capabilities
  • Facilitate risk assessment of inspection outcomes at contract manufacturers and testing labs
  • Coach and mentor junior staff supporting RI program deliverables
  • Other responsibilities as required


Essential Duties and Job Functions:
  • Strong relationship management skills including ability to adapt communication style and content to suit audience and stakeholder needs
  • Strong oral and written communication
  • Demonstrates thorough knowledge of compliance requirements and understanding of current global and regional trends in compliance
  • Ability to analyze, interpret and distill large amounts of information into key messages
  • Ability to operate with incomplete information
  • Accountable to own actions and keep commitments
  • Strives to continuously build knowledge and skills; and shares expertise with others


Knowledge, Experience and Skills:
  • Experience with researching, developing, and delivering RI reports and tools
  • Experience in use of online data sources and scientific/market databases (e.g., fda.gov, PDA, ISPE, Pharma Intelligence)
  • Working knowledge and hands-on experience with risk management tools (e.g., FMEA, risk ranking and filtering)
  • 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)
  • Demonstrated ability to perform in a fast-paced environment


Basic Qualifications:
  • 7+ years of relevant experience in a GMP environment related field and a BS or BA OR 5+ years of relevant experience and a MS.


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

About 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.

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 ‘EEO is the Law' poster.

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