Gilead Sciences
Sr Manager, R&D Quality
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Sr. Manager, R&D Quality
Job Description
The Sr. Manager, R&D Quality will lead and support the execution of GxP audits and inspection readiness activities across Kite’s R&D operations, with a focus on Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). This role will be based in Stockley Park and will support both EU and Rest of World (RoW) audits, compliance and regulatory compliance efforts. The incumbent will contribute to the development and implementation of the annual audit program and play a key role in audit management, regulatory inspections and continuous improvement initiatives.
Key Responsibilities
- Lead internal GxP audits and inspection readiness activities across assigned R&D functions and geographies.
- Act as the primary point-of-contact for regulatory inspections in the EU and RoW regions.
- Provide expert guidance on GCP and GVP compliance, including evolving regulatory requirements.
- Develop and manage CAPAs resulting from audits, inspections, incidents, and deviations.
- Contribute to the development and communication of the R&D Annual Audit Program.
- Represent Kite during regulatory inspections and interactions with health authorities.
- Lead or participate in cross-functional quality improvement projects and forums.
- Provide training and mentorship to junior team members and cross-functional partners.
- Collaborate with global teams to ensure harmonized quality standards and practices.
- May serve as a Compliance Lead for assigned Kite R&D groups, teams, workstreams or projects.
- Expected 30% to 50% travel.
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Qualifications
- Bachelor’s or advanced degree in life sciences or related field.
- Relevant experience in the biopharmaceutical industry, including significant experience in quality, compliance, auditing, and CAPA management.
- Knowledge of the drug development process and application of the principles, concepts, practices, and standards of Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC). Experience leading audits and inspections in the EU and RoW regions.
- Strong knowledge of Quality Management Systems (QMS) and Quality Risk Management (QRM).
- Proven ability to analyze complex systems and data to identify compliance risks and recommend solutions.
- Excellent communication, leadership, and project management skills.
- Certification as a Quality Auditor and experience continuous improvement methodologies preferred.
- Fluent in English; additional European languages are a plus.
Leadership & Collaboration
- Provides matrix management to project teams and may manage direct reports.
Location & Working Arrangements
We are pleased to share that Gilead’s Stockley Park and Holborn offices are planning to come together at a new London headquarters at 1 Triton Square, NW1, from approximately Q2 2027. Applicants should consider this planned location change when applying for this role. Gilead operates a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.
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Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
Application Process
For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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