Senior Manager of Quality Systems

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.

Education and Knowledge Requirements:

• A science related degree in Chemistry, Engineering or Bio-technology

• A minimum of ten (10) 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

• Experience in leading teams

• Knowledge of OPEX tools

• Experience in a GxP Manufacturing site

• Technical writing training / qualification

• Experience in leading or participation in project teams

• Experience in leading teams in a virtual environment

• Lead investigator training (preferred)

• Qualified auditor (preferred)

• Lean Six Sigma qualification (preferred)

• Project Management qualification

Responsibilities

• 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 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 BMS policies/directives 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 or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process

• Regularly 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 remediation

• Own relevant process issues – speak to trends/issues/exceptions at ExM Tier 3 Quality Councils

• Own Health Authority commitments related to the process

• Act as the subject matter expert in audits / inspections

• Develop and implement pro-active continuous improvement plans for the process for example Value

• Stream Mapping and identification of weak elements, regulatory surveillance

• Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management.

• Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyze data and information

• Other Ad hoc duties will be required which will include, but not be limited to, the following:

• Author, review and approve Quality Management System (QMS) documents

• Process QMS documents in the electronic document management system

• Oversee Permanent Inspection Readiness activities

• Escalate risks for inclusion in the Quality Risk Register for ExM

• Responsible for the Document Management and Record Management systems

• Responsible for the ExM Training Program

• Oversee the system for maintenance of ExM GxP Authorizations

• Act as facilitator and reviewer of Global procedures

• Act as ExM Quality Systems representative on ExM and Global Quality projects

• Lead self-inspection audits

• Review regulatory inspection observations from other BMS sites for site compliance

• Identify and implement continuous improvement opportunities for Quality Systems owned processes

Manage People

• Provide regular feedback and coaching to reports

• Develop direct reports through coaching, mentoring, training and providing them with development opportunities

• Build a team culture committed to high performance

• Build effective working relationships both internally within EXM and within Bristol Myers Squibb (BMS)

Travel- There will be 10% travel associated with this role.

BMSBL

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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