Sr. QA Specialist - QC Support

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

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Job Description
 

We are seeking a highly motivated individual to join us as a Sr. QA Specialist for the Gilead La Verne Quality Assurance Department. This role involves collaborating with cross-functional teams to ensure the QC testing comply with Quality and Regulatory requirements through its lifecycle.

Responsibilities: 

• Monitor industry practices and relevant regulatory and pharmacopoeia guidance for biological product testing to ensure compliance. Lead gap assessments and mitigation plans as needed

• Review and approve biological test methods and method validation/transfer reports 

• Review and approve lab investigations associated with release testing and method validation/transfer at the site or contract testing laboratories

• Support biological product sample management (e.g., reserve, reference standards) and cell bank management

• Liaise with cross-site QAs and Analytical Leads to resolve issues and improve practices and workflow efficiency

• Lead the QA review of analytical data, including data audit trails; Manage and train QA specialists on activities related to QA support of analytical activities

• Review and approve biological analytical instrument qualification protocols and reports as needed

• Manage cross-functional teams, including organizing and prioritizing daily tasks

• Participate in authoring, review, and approval of new or revised standard operating procedures, specifications, forms, test methods and other controlled documents to ensure high quality documents and compliance with current Good Manufacturing Practices (GMPs)

• Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives

• Participate in review and approval of Deviations, CAPAs, and Change Management records as required

• Participate in the QA oversight of stability program and lifecycle management of test method initiatives

• Communicate with cross-site teams to align practices and drive continuous improvement

• Deliver biological GMP training to the QA/QC group

Qualifications: 

• Bachelors Degree and 6+ years of experience required OR

• Masters Degree and 4+ years of experience required OR

• Experience with biological method development, verification, validation and transfer required

• Familiar with biological product (excipient, drug substance and/or drug product) specification development desired

• Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements, ICH Q2/Q14/M10, and USP 1220>

• Experience across broad areas of Quality Assurance and/or Quality Control Systems

• Demonstrated ability to develop, coach and mentor employees

• Excellent interpersonal, verbal, and written communication skills

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred

The salary range for this position is: $121,125.00 - $156,750.00. 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 [email protected] for assistance.
 

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.