At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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 a permanent Manager, Quality Systems.

The Manager, Quality Systems is responsible for implementing, supporting and monitoring the effectiveness of the Quality Systems within the Global External Manufacturing (ExM) organization.

Key Duties and Responsibilities:

Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.

Process Ownership

• The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
• Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
• Act as primary ExM representative at Global Community of Practice meetings
• Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
• Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable
• Display technical knowledge of the process and understand risks/weaknesses in the system
• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with Bristol Myers Squibb (BMS) policies / global procedures where applicable
• Responsible for ensuring the elements of the process are current and reflect current practices
• Be primary subject matter expert for review of regulatory changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
• Ensure appropriate Key Performance Indicators are in place to measure the effectiveness of the system within ExM
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimisation) for their effectiveness and provide feedback to the Quality management team for action and remediation
• Own relevant process issues
• Develop and implement pro-active continuous improvement plans for the process

Operations Support

• The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
  • Processing of Customer Complaint records, including escalation of expedited complaints
  • Support the processing of deviation investigations, CAPAs and change controls
  • Perform initial impact assessment of Global change controls that may impact ExM Operations
  • Participate in Virtual Plant Team (VPT) meetings as appropriate
  • Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required
  • Facilitate tracking of CMO Health Authority inspection observations and CAPAs
  • Escalate any emerging trends / issues to the VPTs, as required.
  • Provide Quality input ad hoc queries relating to ExM Operations

• Other ad-hoc duties will be required which will include, but not be limited to, the following:
  • Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location
  • Author, review and approve Quality Management System (QMS) documents
  • Process QMS documents in the electronic document management system
  • Participate in and support Permanent Inspection Readiness activities
  • Maintain the Quality Risk Register for ExM
  • Monitor the periodic review of Quality Systems documents
  • Maintain the system for update of ExM GxP (Good Practice) Authorizations
  • Act as facilitator and reviewer of global procedural updates through the GPO network
  • Act as ExM Quality Systems representative on ExM and Global Quality projects
  • Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits
  • Support preparation of and participate in Quality Council meetings
  • Perform self-inspection audits as part of the audit team
  • Review regulatory inspection observations from other BMS sites for site compliance
  • Identify and implement continuous improvement opportunities for Quality Systems owned processes
  • Act as qualified training for Quality Systems owned processes

• There will be 5% travel associated with this role.

Qualifications, Knowledge and Skills Required:

• A science related degree in Chemistry, Engineering or Biotechnology or equivalent
• A minimum of seven (7) years’ experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
• A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
• Knowledge of OPEX tools
• Experience in leading or participation in project teams

Essential

• Works under minimum supervision and exhibits a positive work attitude and high productivity
• Detail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skills
• Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines
• Excellent interpersonal skills
• Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated
• Strong presentation skills; confident public speaker
• Ability to multi-task numerous projects
• Ability to achieve targets and milestones
• Can prioritize workload based on changing business needs
• Ability to recognize topics / decisions requiring escalation
• Ability to work with initiative and manage own workload
• Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
• Fluent English is required. For roles based in Switzerland, French is also desired.
• Strong working knowledge of Microsoft Office
• Lean Six Sigma qualification
• Project Management qualification
• Supervision of work of direct or indirect reports

Desirable

• Experience in a GxP Manufacturing site
• Technical writing training / qualification
• Lead investigator training
• Qualified auditor
• Lean Six Sigma qualification
• Project Management qualification
• Supervision of work of direct or indirect reports

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

• Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
• Innovation: We pursue disruptive and bold solutions for patients.
• Urgency: We move together with speed and quality because patients are waiting.
• Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
• Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
• Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

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, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus

#LI-Hybrid

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.