
Sr Manager, Quality Assurance & Responsible Person
爱尔兰 - 都柏林制造运营和供应链正式员工职位描述
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)