Sr. QA Specialist - QC Support

Job Description

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

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

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*.