Overview
Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that goes beyond the ordinary, with opportunities to grow and thrive across departments. From optimizing a production line to breakthroughs in cell therapy, this work transforms the lives of patients and the careers of those who do it.
Bristol Myers Squibb recognises the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs to help employees pursue their goals, at work and in their personal lives. Read more at careers.bms.com/working-with-us.
Company Presence - Ireland
Bristol Myers Squibb has been operating in Ireland since 1964, employing over 650 people across a range of activities and business units. Located in Dublin, Cruiserath Biologics Campus is a one billion Multi-Product Cell Culture Biologics Manufacturing facility central to Global Product Development and Supply. The Global Biologics Laboratory (GBL) responsible for release testing of biologics drug product is also based on the Cruiserath Campus. BMS Cruiserath has been awarded Biopharma Company of the Year 2019 and is certified as a Great Place to Work since 2017, including recognitions for women in 2020, 2021 and 2022.
Job Summary
This position is responsible for providing investigative 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 current Good Manufacturing Practices required by the job function.
Key Duties and Responsibilities
* Perform investigations using the eQMS (Infinity) system for supplier complaints, including but not limited to BMS and supplier 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 procedures 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; monitor and ensure actions are implemented and closed on time with status updated in the related quality system. Escalate to supervisor and site procurement lead if issues arise.
* Create detailed activity plans using project management tools.
* Provide support, training and development to suppliers and internally to avoid recurrence of BMS and supplier issues.
* Implement processes and procedures to address supplier performance deficiencies.
* Ensure compliance with corporate and site procedures, cGMPs and other industry guidelines.
* Apply Lean Six Sigma tools to reduce investigations with proper corrective, preventive and proactive actions.
* Manage and execute supplier programs for 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 processes.
* Proven track record of successfully managing projects and developing & implementing quality processes in a pharmaceutical environment.
* Strong customer service orientation with excellent analytical, interpersonal communication and negotiating skills.
* Proactive, creative and analytical approach.
* Strong understanding of supplier development and supplier quality is required.
* Ability to multitask with a sense of urgency; capable of short-term execution and long-term strategic thinking.
* Ability to interface with external and internal resources at all levels.
* Demonstrated hands-on supplier management implementation in regulatory contexts (e.g., FDA, ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA, among others).
* Ability to communicate effectively within a matrix organization and to sell ideas, services and solutions across functions.
* Demonstrates leadership, interpersonal, communication, and motivation skills; excellent writing and oral communication 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 receive a competitive salary and 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.
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 you are assigned is determined by the nature and responsibilities of your role.
Site-essential roles require 100% of shifts onsite. Site-by-design roles may be eligible for a hybrid model with at least 50% onsite. Onsite presence is essential for collaboration and culture. Field-based and remote-by-design roles require travel to visit customers, patients or partners as directed.
BMS is committed to accessibility and reasonable workplace accommodations. Applicants can request accommodations before accepting a job offer. For inquiries, contact adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement.
BMS recommends vaccination and staying up to date with Covid-19 boosters to support well-being. BMS will consider qualified applicants with arrest or conviction records where allowed by law.
If you live in or will work from Los Angeles County, please review important information at careers.bms.com/california-residents/.
Data from role applications will be processed in accordance with applicable data privacy policies and regulations.
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