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The Position
The Quality and Compliance Lead (QCL) is the Quality and Compliance expert within the Medicine Division that drives GvP / GcP topics across the BI organization to pro-actively manage Quality and Compliance across the drug/device development. In addition, the QCL will also lead the organization to identify and mitigate risks during development to ensure patient safety and data integrity.
This role will also initiate and manage any quality and compliance topics to continuously improve the Medicine Quality Management System across ROPU ASKAN. The QCL provides quality and compliance consultancy within the regional operating unit (R)OPU), while contributing to (R)OPU insights into the Global Quality Medicine Strategy and execute the strategy at (R)OPU level.
Duties & Responsibilities
Develop and maintain all aspects of the global Medicine Quality Management System and tailoring to the (R)OPU to comply with applicable regulatory requirements.
Lead the implementation and maintenance of global procedures and ensure adherence to the local regulatory and business requirements.
Lead inspections end to end (inspection preparation, conduct and post inspection management), representing the BI compliance position during inspections and ensuring inspection findings are addressed and responses provided.
Ensure audit findings are appropriately investigated, actions are effectively implemented, and lessons learnt are implemented
Define requirements for services needed by (R)OPU in collaboration with Medicine Functions.
Provide quality analysis and trending across Medicine Functions.
Lead as the subject matter expert (in partnership with the business key stakeholders) in Non-Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation and CAPA development delivering robust CAPAs
Requirements
Master's degree preferred or Bachelors in a life science or other scientific discipline with several years of work experience
Minimum 1 to 2 years of experience in Quality and Compliance related job
Experience in pharmacovigilance, regulatory affairs, medical affairs or clinical trial management and expert in ICH GcP, GvP and applicable regulations
Direct experience with / participation in regulatory authority inspections or audits
Proven track record of effective collaborations with business partners
Ability to act independently on given tasks and be a good team player
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.