Manager, Supplier Compliance

7 days ago


Dublin, Dublin City, Ireland Bristol Myers Squibb Full time
Overview

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 Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility, plays a central role in the Global Product Development and Supply network as the company\'s first European biologics manufacturing facility. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.

Job Summary

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities
  • Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier\'s processes.
  • Create and execute Corrective Actions and Preventive Actions (CAPA).
  • Prepare, submit and discuss findings of the investigation process with key stakeholders.
  • Lead global investigations in collaboration with Global Quality Supplier Leads, BMS Site Supplier Quality, and SQE teams.
  • Perform trending analysis of site events and complaints. Investigate and root-cause no-fault found investigations and implement internal process improvements to prevent recurrence.
  • Generate, review and implement procedure and forms to assure compliance with current practices or GMP trends.
  • Provide support to the supplier development team preparing quarterly data for Quality Council and governance meetings.
  • Evaluate and improve supplier complaint investigation and material return processes.
  • Create, evaluate, follow up and approve Change controls for the assigned site, including interaction with corporate support areas, other BMS sites and third parties.
  • Ensure Change controls are created according to approved SOPs and corporate directives with all the appropriate requirements in place for each change control, monitor and ensure actions are implemented and closed on time and status updated in related quality system. Escalate to supervisor and site procurement lead in case of issues.
  • Create detailed plans of the activities using Project Management tools.
  • Provide support, training and development to the suppliers and internally to avoid BMS and Suppliers issues recurrence.
  • Implement processes and procedures to address supplier performance deficiencies.
  • Ensure compliance with corporate and site procedures, cGMPs regulations and other industry guidelines.
  • Apply Lean Six Sigma tools to reduce investigations establishing proper corrective, preventive and proactive actions.
  • Manage and execute supplier program for the investigation and resolution of deviations, CAPA, and complaints.
  • Provide oversight of suppliers performing investigations, change controls, protocols and reports in support of BMS products.
  • Support additional projects, QMS initiatives, or standard work assignments as needed.
  • Daily contacts with SQE Team, Global Supplier Management Team, MS&T Scientists, Site Supply Chain Buyers and Site Quality Management.
Qualifications, Knowledge and Skills
  • Bachelor\'s degree in Business, Science or Engineering.
  • Six (6) years of experience in Quality, Purchasing, or Manufacturing Technology (Technical Services) within the pharmaceutical, biologics, cell therapy, or medical device industry.
  • MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience is a plus.
  • At least 3 years handling investigations process.
  • At least 3 years handling change control process.
  • Proven track record of successfully managing projects, and responsible for developing & implementing quality processes in a pharmaceutical environment.
  • Strong customer service orientation with excellent analytic, interpersonal communication and negotiating skills.
  • Proactive, creative and analytic approach.
  • Strong understanding of supplier development & supplier quality experience is a must.
  • Short-term execution and long-term strategic thinking capabilities, ability to multitask with a sense of urgency.
  • Ability to interface with external resources and internal resources at all levels.
  • Demonstrated hands on supplier management implementation in regulatory agencies like FDA, ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA among others.
  • Ability to communicate effectively within a matrix organization.
  • Effective at selling ideas, services and solutions to others at different organizational levels and functions.
  • Demonstrates leadership, interpersonal, communication, and motivation skills.
  • Excellent writing and oral communication skills are required.
Working Conditions
  • No exposure to hazards or disagreeable conditions.
  • Travel required: 10% of the time.
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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym.

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.

On-site Protocol and Company values: Transforming patients\' lives through science, with a culture of passion, innovation, urgency, accountability, inclusion and integrity.

Equal Employment Opportunity: BMS is committed to an inclusive recruitment process; inquiries can be directed to Read more at


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