QA Specialist III

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: QA Specialist III

Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.

Essential Duties and Job Functions:

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Serves as Analytical Operation Lead for clinical and commercial projects
• Leads quality investigations/deviations/quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner.
• Reviews and approves method validation and/or transfer documents including protocols, reports, methods, change controls and specifications for small molecules and/or large biologics for analytical operations, and contract labs/manufacturers across the clinical and commercial supply chains.
• Reviews and audits method validation related data in CMC sections of NDA / global filings.
• Responsible for maintaining current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
• Interfaces with operating entities and contract partners to address documentation and compliance issues and ensure successful project completion.
• Leads department projects of varying complexity.
• As a quality functional site lead at CTLs, supports quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments.
• Participates on projects, initiatives, and process improvements.
• May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.

Knowledge, Experience and Skills:

• Possesses experience/knowledge in laboratory controls, method validation and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines.
• Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
• Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards.
• Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys).
• Working knowledge of Risk Management Tools (e.g. root cause analysis, decision trees, risk registers).
• Experience in a Pharma / Biotech GMP environment and a Bachelor's degree in chemistry, biology, or related scientific field.
• Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations.
• Demonstrates excellent verbal, written, and interpersonal skills.
• Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
• Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
• Possesses critical thinking skills when making sound quality decisions based on risk management and available data.
• Has proven analytical and conceptual skills.
• Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership.

Basic Qualifications:

• 6+ years of experience in a GMP environment related field and a BS or BA.
• 4+ 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/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.

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.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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