Senior Manager, CSCQ, Qualified Person

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. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

The Role

The position is a management position within the Global Product Supply (GPS) Pharma Product Development (PD) 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 & third party logistics risk management. This position provides leadership for the identification and resolution of critical quality issues that may affect BMS.

This is a 12 month fixed term contract role.

Key Duties and Responsibilities:

Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to:

• Review and approval of QA related procedures
• Support preparation and approval of training materials
• Support review and approval of Quality Agreements
• Ensure knowledge transfer from current release site
• Support Manufacturer(s)/Importation Authorisation and Wholesale Distribution Authorisation submissions as required
• Support regulatory inspections in the capacity of subject matter expert and host, as applicable

Support sustaining operations, including but not limited to:

• Quality Assurance preparation to support Qualified Person release of IMP’s
• Support Health Authority GMP/GDP inspections and audits across the supply chain, Support GCP HA inspections where required.
• Oversees/provides CSC Compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
• Oversee Site Master File maintenance
• Oversee Manufacturer(s)/Importation 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
• Oversee QA activities including but not limited to: Use Date Extension, Generic Labelling activities, CoC generation, Israel release documentation
• Review and approve procedural documents
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs
• Supervises QA Operations personnel (Manager, Senior Specialist) as assigned
• Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives

Qualifications, Knowledge and Skills Required:

Education/Experience/ Licenses/Certifications:

University degree (science degree preferred).

Experience in team leadership.

Knowledge of up to date GMP compliant Quality Management System implementation especially with clinical GMP requirements.

Experience with investigation and incident management.

Experience with audits and inspections. Knowledge of clinical pharmaceutical requirements. Experience in communicating with regulatory authorities. Experience with making significant quality decisions

Travel: This position requires up to 10% of travel

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.