Associate Director, Clinical Supply Chain Quality

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb Ireland:
Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

The Role:
BMS External Manufacturing is looking to recruit on a permanent contract an Associate Director, Clinical Supply Chain Quality, reporting to the Director of Clinical Supply Chain Quality. The position is a management role within the Pharma Quality organisation that is responsible for the oversight of CSC Quality activities including CSC Logistics EMEA/ASIA PAC operations. The position is responsible for the Quality of Supply Chain related activities including but not limited to processes such as Use Date Extensions, ISR studies, IMP supply and management at sites & 3rd party logistics risk management. This position provides leadership for the identification and resolution of critical quality issues that may affect BMS.

Key Responsibilities and Major Duties:
Support start-up activities for Clinical Supply Quality Dublin, may include but not limited to:

• Review and approval of QA/QP-related procedures
• Support preparation and approval of training materials
• Support review and approval of Quality Agreements
• Ensure Knowledge transfer from current release site
• Support Manufacturers Authorisation submissions
• Support related regulatory inspection in the capacity of Subject matter expert and host as applicable

Support sustaining operations, may include but not limited to:

• Qualified Person release of IMP’s
• Accountable for Health Authority GCP/GDP inspections and audits across the supply chain
• Oversees/provides CSC compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
• Develop and implement quality strategy to oversee vendor quality (3PLs)
• Incorporate global regulatory trends and changes into Supply Chain Quality
• Oversee Site Master File maintenance
• Oversee Manufacturers Authorisation update and maintenance
• Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management
• Review and approve procedural documents
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• May influence the external environment through interactions with regulators, trade associations, or professional societies
• Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs.
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
• Supervises QA Operations personnel (Senior Manager, Manager) as assigned
• Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives
• Delegate for Director, CSC Quality, Dublin

Adherence to BMS core behaviors

Qualifications, Knowledge and Skills Required:

• University degree (science degree preferred). Eligibility to act as an EU Qualified Person. i.e. either an EU Pharmacy degree or other equivalent qualification
• Minimum of 3 years experience working in Quality in Pharmaceutical company
• Experience as a Qualified Person required
• Experience in team leadership
• Knowledge of up to date GMP compliant Quality Management System implementation especially with clinical GMP requirements
• Experience with investigation and in