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 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.
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.
For more information about Bristol Myers Squibb, visit us at BMS.com/ie
The Role
BMS External Manufacturing is looking to recruit on a Fixed Term Contract (12 months) Senior Manager, Quality Systems, reporting to Associate Director, Quality Systems.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs
Key Duties and Responsibilities:
The Quality Systems Senior Manager is responsible for ensuring the effective implementation of Quality Systems and Training within the Global External Manufacturing organization.
Manage People
Provide regular feedback and coaching to reportsDevelop direct reports through coaching, mentoring, training and providing them with development opportunitiesBuild a team culture committed to high performanceBuild effective working relationships both internally within EXM and within Bristol Myers Squibb (BMS)Process Ownership
The Quality Systems Senior Manager will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing.The Quality Systems Senior Manager will also be accountable for overseeing the work of Process Owners within their teams.Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicableDisplay technical knowledge of the process and understand risks/weaknesses in the systemResponsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/directives where applicableResponsible for ensuring the elements of the process are current and reflect current practicesBe primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the processRegularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediationOwn relevant process issues – speak to trends/issues/exceptions at ExM Tier 3 Quality CouncilsOwn Health Authority commitments related to the processAct as the subject matter expert in audits / inspectionsDevelop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillanceProcesses include Deviation Investigations, Corrective Action / Preventive Action (CAPA), complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management.
Operations Support
The Quality Systems Senior Manager will be responsible for ensuring appropriate support is provided by Quality Systems teams to ExM Operations from a Quality Systems and Training perspective on a day-to-day basis.Evaluate metrics collection and processing, including:Capture and report on Quality data and metrics for management review and other organizational forumsUtilize data analysis or software skills to build on existing tools to improve the quality system processesCollect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyse data and informationOther Ad hoc duties will be required which will include, but not be limited to, the following:Author, review and approve Quality Management System (QMS) documentsProcess QMS documents in the electronic document management system Oversee Permanent Inspection Readiness activitiesEscalate risks for inclusion in the Quality Risk Register for ExMResponsible for the Document Management and Record Management systemsResponsible for the ExM Training ProgramOversee the system for maintenance of ExM GxP AuthorizationsAct as facilitator and reviewer of Global proceduresAct as ExM Quality Systems representative on ExM and Global Quality projectsOversee the scheduling, execution, reporting, follow up and tracking of self-inspections auditsResponsible for the preparation of Quality Council meetingsLead self-inspection auditsReview regulatory inspection observations from other BMS sites for site complianceIdentify and implement continuous improvement opportunities for Quality Systems owned processesAct as qualified trainer for Quality Systems owned processesThere will be 10% travel associated with this role.
Qualifications, Knowledge and Skills Required:
A science related degree in Chemistry, Engineering or Bio-technologyA minimum of ten (10) years’ experience in a pharmaceutical Quality related role, preferably within a Quality Systems teamA strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global marketsExperience in leading teamsKnowledge of OPEX toolsExperience in a GxP Manufacturing siteTechnical writing training / qualificationExperience in leading or participation in project teamsWorks under minimum supervision and exhibits a positive work attitude and high productivityDetail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skillsCandidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelinesExcellent interpersonal skillsAbility to lead, coach and motivate team members across diverse geographical locationsAbility to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are requiredSelf-motivatedStrong presentation skills; confident public speakerAbility to multi-task numerous projectsAbility to achieve targets and milestonesCan prioritize own workload and workload of the team based on changing business needsAbility to make decisions based on business and GxP riskProficient in the use of Microsoft Office programs including OneNote and SharePoint platformsFluent English is required.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 annual leave, access to BMS Cruiserath on-site gym and life assurance.BMSBL
#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 an inclusive culture, promoting diversity 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 a diverse 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/
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