Director, Quality Assurance - Quality Risk Management
Director, Quality Assurance - Quality Risk Management
United States - California - La Verne
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 matter, 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.
We are seeking a highly motivated leader to join the QA Technical organization as a Director of Quality Assurance at San Dimas and La Verne sites to lead the Quality Risk Management (QRM) program and manage QA support for GMP capital projects. The Director will provide vision and leadership in integrating QRM across the sites to meet the changing regulatory and compliance expectations. The Director will also provide quality and compliance oversight across a wide range of technical area, including cleaning validation, routine QC instrument qualification, capital projects for QC labs, GMP warehouses, manufacturing and packaging facility, etc. In addition, the Director will have the opportunity to join other QA leadership in hosting PAI and routine GMP inspection by health authorities around the world.
This position is based in Gilead's manufacturing plant in La Verne, California, and is eligible for the GFlex program, in which employees are eligible to work from home up to 3 days per week.
Essential Job Functions and Responsibilities:
- Lead, improve, and manage the sites\' QRM program that includes risk identification, evaluation, reduction, communication, and reviews.
- Lead sites' cultural changes in integrating QRM principles across all GMP functions areas and implement QRM facilitator training program.
- Establish processes to prioritize risk management efforts across key product lines and processes.
- Lead critical or large scope risk assessment to ensure sound scientific approach
- Develop, improve, and maintain site risk register, communication plan, and mitigation tracking.
- Organize and conduct routine reviews of high-risk or high-impact areas to ensure effective mitigation and proactively identify potential risks.
- Lead facility design risk assessments and mitigations and support the development and updates of the sites' cross contamination control strategy.
- Serves as a point of contact for Corporate and cross-site QRM program activities and application systems
- Maintain QA oversight in the sites' cleaning committee and cleaning validation program.
- Review and approve GMP documents related to engineering and validation activities, including protocols, reports, memos, etc., as well as other GMP documents such as major deviations, change controls, trend report, procedures, policies, and annual product reviews.
- Budget, recruit, and maintain appropriate resources to effectively manage the team responsibilities.
- Interacts with Gilead's senior management on matters concerning QRM, projects, and/or the functional area we support. Manages key relationships with external stakeholders.
- Train and mentor staff; organize and prioritize tasks; and manage employee performances and reviews.
- Provide backup support for a wide variety of activities to ensure compliance with quality systems, procedures, policies to facilitate compliance with regulatory, customer and MA holder requirements.
- Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies, in meetings, communications, and inspections.
- Keep up with current compliance requirements and industry best practice through published information and papers, benchmarking, and attending industry and regulatory agency sponsored meetings and seminars.
Knowledge, Experience and Skills:
- Possess knowledge and application experiences of Quality Risk Management, including ICH Q9, and related US and EU regulatory requirements and Guidances
- Is an SME in applying various risk assessment tools and other elements to enable an effective approach to execution and training.
- Possess strong technical background in pharmaceutical engineering and validation principles and practices. Specific knowledge in cleaning validation is a plus.
- Demonstrates an in-depth understanding and application of the broader GMP principles, concepts, practices and standards in the US and internationally.
- Demonstrates strong knowledge of pharmaceutical manufacturing, aseptic processing, packaging and labeling. Specific knowledge in cross contamination control design and strategy is a plus.
- Demonstrates substantial knowledge of industry best practices and trends.
- Is comfortable interacting with regulatory agencies in inspections.
- Demonstrates a highly developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance and is capable of assessing and communicating the impact of these requirements to the business.
- Demonstrates ability to establish credibility with diverse audiences and demonstrate leadership.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- 10 + years of relevant experience and a bachelor's degree in science or related fields OR 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior people management experience.
- Broad experience across areas like QA, Validation, QC, and understanding of Parenteral, Aseptic manufacturing operations is beneficial.
- Biopharmaceutical or Pharmaceutical experience preferred.
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.
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.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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