Senior Associate Scientist, External Quality Analytical Oversight

Key Responsibilities

• The Senior Associate Scientist in External Quality Analytical Oversight role supports external commercial QC through hands-on execution of activities and processes related to data review, documentation, method lifecycle support, and continuous improvement. Working within established procedures and with guidance from senior colleagues, the role helps ensure accurate, timely, and compliant QC deliverables.
• Focus Areas
• Perform review of external QC laboratory data for commercial release and stability testing, including contract testing laboratory (CTL) Certificates of Analysis (CoA), stability reports, and supporting documentation, in accordance with Gilead procedures for oversight of contract laboratory data.
• Perform data-based review of CTL raw data packages, including verification of method conditions, sample and standard preparation, reference standard use, system suitability, representative chromatograms, and calculation accuracy; support Level 3 on-site data reviews as assigned.
• Use lab information management system (LIMS) to verify accurate transcription of results against CTL documents and specifications, complete test- and sample-level review and authorization, review audit trails, and generate provisional CoAs, Stability Summary Reports, and Analytical Reports.
• Use electronic documentation management system to retrieve, review, and accept CTL CoAs, stability reports, raw data packages, specifications, and test methods; maintain document metadata and workflows and document data review findings and discrepancies.
• Partner with QC Leads, CTLs, and QA to resolve data discrepancies, request and track CTL corrections, and ensure data review is completed within required turnaround times.
• Identify, document, and escalate data review findings, including atypical results, trends, and data integrity or ALCOA++ concerns; support related laboratory investigations (OOS/OOT/OOE), deviations, and CAPAs.
• Compile and report QC data-related metrics, maintain review and batch release trackers, and communicate status, turnaround times, and outstanding issues.
• Coordinate SAP specification authoring and updates with designated authors and QC stakeholders, tracking completion and confirming alignment with approved specifications.
• Contribute to continuous improvement of data review processes and electronic system workflows, including authoring or revising SOPs, work instructions, and job aids and supporting system changes and user testing.

Experience:

• You have:
• Experience with Commercial Quality Control, analytical development, or a related laboratory environment.
• Working knowledge of GMP principles, data integrity expectation of lab data, and applicable procedures and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Demonstrated ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead’s GMP policies.
• Demonstrated the ability to influence process and outcomes across functions.
• BS degree in Chemistry, Biochemistry or related field with 5+ years of relevant experience OR
• MS degree in Chemistry, Biochemistry or related field with 3+ years of relevant experience
• Knowledge and experience in commercial quality control.
• Stays ahead of shifting trends in industry.
• Ability to think critically, analyze information, and work independently on defined assignments while seeking guidance when needed.
• Strong organizational, planning, and attention-to-detail skills.
• Effective verbal and written communication skills and a collaborative working style.
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
• 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.
• Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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.
• For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
• NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
• YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
• Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
• 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.
• Please apply via the Internal Career Opportunities portal in Workday.

Requirements:

• Leader Accountabilities:
• The salary range for this position is: $117,895.00 - $152,570.00. 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:

For jobs in the United States:

For Current Gilead Employees and Contractors:

Preferred Qualifications

• The salary range for this position is: $117,895.00 - $152,570.00. 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.