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Manager, supplier compliance

Dublin
My Next Stage
Supplier
€80,000 - €100,000 a year
Posted: 14h ago
Offer description

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.

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 (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. 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

Key Duties and 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 finding 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 reoccurrence.

* Generates, reviews and implements procedure and forms to assure compliance with current practices or GMP trends.

* Provides support to the supplier development team preparing quarterly data for Quality Council and governance meetings.

* Evaluates and improves supplier complaint investigation and material return process.

* Creates, evaluates, follows up and approves Change controls for the assigned site, including interaction with corporate support areas, other BMS sites and third parties.

* Ensures Change controls are created according to approved SOPs and corporate directives with all the appropriate requirements in placed for each change control, monitor and ensure actions are implemented and closed on time and status up-dated 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.

* Provides support, training and development to the suppliers and internally to avoid BMS and Suppliers issues recurrence.

* Implements 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.

* Manages and executes supplier program for the investigation and resolution of deviations, CAPA, and complaints.

* Provides oversight of suppliers preforming 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 Required:

* 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.

* Must have 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

* Describe exposure to any hazards/disagreeable in the work environment:

* No exposure to hazards or disagreeable conditions.

* Travel required (describe nature and frequency):

* 10% of the time

Why you should apply

* You will help patients in their fight against serious diseases

* You willbe part ofa 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

#LI-Hybrid

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.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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

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