Senior QA Specialist - Analytical Science and Technology
United States - New Jersey - Morris PlainsUnited 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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to apply for this job.Job Description
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.Senior QA Specialist - Analytical Science and TechnologyRole and Responsibilities:
The team will possess a detailed understanding of Analytical QA in support of large molecule manufacturing. These roles will have responsibility for supporting GMP activities at as multiple external contract testing sites, internal and external method establishment, product performance monitoring, existing methods and specifications, reference standard programs, QC impacting change controls, and analytical investigation oversight.Essential Duties and Job Functions:
Providing QA oversight to PDM Biologics Analytical Operations and Contract test partners (i.e., CTLs and CMO Labs) in support of analytical testing activities across clinical and commercial programs for external manufacturing operations.
Knowledge, Experience and Skills:
- Reviews and approves method validation and transfer related documentation and exception events.
- Partners with Commercial and Development Quality Assurance Biologics colleagues to ensure testing requirements are met in a timely and compliant manner in alignment with manufacturing and release expectations.
- Manages daily QA team activities, leading major planned changes and exceptions, method validation and transfer related documents, deviations, investigations.
- Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders.
- Serves as QA project lead, leads complex quality issues and events, represents QA on Materials Review Boards and escalations as the Analytical QA expert, and authors concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
- Varying levels of knowledge in laboratory controls and method validation per FDA/EU/ICH/USP guidelines.
- Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
- Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
- B.A/B.S. or higher degree in analytical chemistry, biochemistry, pharmaceutical development or equivalent degree preferred
- Work independently and as a Team member with Integrity | Precision | Accomplishment | Principled Ambition | Respect
- Working in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, or Technical function supporting testing operations or related industry experience in the laboratory
- Analytical aptitude, critical thinking skills and ability to apply key concepts
- Speaks with courage and candor
- Strong and principled written and verbal communication skills
- Ability to manage multiple projects/tasks simultaneously
- Demonstrated decision-making responsibility
- Project Management, Change Execution Management and Team Leadership experience
- Demonstrated collaboration skills including flexibility, inclusive behaviors, and the ability to work in a team environment
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Expert deviation management abilities
- Demonstrated facilitative leadership skills and able to lead teams to deliver results
- In-depth working knowledge and application of GMPs/GLPs
- 7+ years of experience in a GMP environment related field and a BS or BA.
- 5+ years of relevant experience and a MS.
- Prior experience in the pharmaceutical industry is required.
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/GileadAbout 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 firstname.lastname@example.org
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