Sr Manager, Quality Assurance & Responsible PersonExperience Level: Senior Level | Posted Date: 14/04/2025
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
Gilead Sciences Ireland UC is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Sr Manager, Quality Assurance (Wholesale Distribution Authorisation Responsible Person) - Global Product Distribution & Affiliates.
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead’s global logistics operations, with primary responsibility as Responsible Person for EU based operations.
Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements.
Supports Global and Regional QA teams as well as working cross-functionally with Global Logistics, Supply Chain, Warehouse, Customer Service personnel as well as Facilities, EHS and Validation colleagues in all aspects of product distribution.
Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues.
Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.
Reviews shipping records, environmental monitoring and associated data relating to product distribution activities.
Hosts HPRA inspections and interacts closely with external regulators/stakeholders.
Co-hosts/supports external FDA audits and internal audit programs.
Participates in the development & delivery of training programs regarding relevant to Global product Distribution.
Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations.
Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards.
Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.
Knowledge, Experience & Behaviours:
Experience as a WDA listed Responsible/Deputy Responsible Person.
Experience in Global Product storage & distribution, including cold chain and Ultra-Low Temperature materials.
Demonstrates proficiency in EU & HPRA Good Distribution Practices (GDP).
Demonstrates working knowledge with good proficiency in Microsoft Office applications.
Experience in providing QA oversight of contracted 3PL activities.
Resilient profile with the ability to deliver in a challenging environment.
Ability to engage and manage multiple stakeholders to achieve the objective.
Organised with systematic approach to prioritisation.
Positive attitude
Motivated to learn new skills and embrace new experiences.
Gilead Core Values:
• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)
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.
Please apply via the Internal Career Opportunities portal in Workday.