Sr Manager, R&D Quality

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

The Sr. Manager R&D Quality will lead and support the execution of GxP audits and inspection readiness activities across Kites 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

Qualifications

Bachelors 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.

We are pleased to share that Gileads Stockley Park and Holborn offices are planning to come together at a new London headquarters at 1 Triton Square NW1 fromapproximately Q22027. Applicants should consider this planned location change when applying for this role. Gileadoperatesa flexible working policy offering a balanced approach with two days of remote working and three days working onsite.

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 individuals 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.

Please apply via the Internal Career Opportunities portal in Workday.