Senior Manager, Quality Compliance

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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

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BMS External Manufacturing is looking to recruit a fixed-term Senior Manager Quality Compliance.

This an 18 month fixed term contract.

The Quality Compliance Senior Manager is responsible for ensuring the effective implementation of Quality Systems within the Global External Manufacturing organization.

Process Ownership

• The Quality Compliance Senior Manager will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing.
• 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 Audits and Inspections and Supplier Management.

Operations Support

• The Quality Compliance Senior Manager will be responsible for ensuring appropriate support is provided teams to ExM Operations.
• Evaluate metrics collection and processing including:
  • Capture and report on Quality data and metrics for management review and other organizational forums
  • Utilize data analysis or software skills to build on existing tools to improve the quality system processes
  • Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect compile and analyse 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
  • Oversee the system for maintenance of ExM GxP Authorizations
• Act as facilitator and reviewer of Global procedures
  • Act as ExM Quality representative on ExM and Global Quality projects
  • Oversee the scheduling execution reporting follow up and tracking of self-inspections audits
  • Responsible for the preparation of Quality Council meetings
  • Lead self-inspection audits
  • Review regulatory inspection observations from other BMS sites for site compliance
  • Identify and implement continuous improvement opportunities for owned processes
  • Act as qualified trainer

There will be 10% travel associated with this role.

QualificationsKnowledge and Skills Required:

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 lead coach and motivate team members across diverse geographical locations
• 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 own workload and workload of the team based on changing business needs
• Ability to make decisions based on business and GxP risk
• Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms

• Fluent English is required.

Required

• 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

Desirable

• Experience in leading teams in a virtual environment
• Lead investigator training
• Qualified auditor
• Lean Six Sigma qualification
• Project Management qualification

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.
• Youll get a competitive salary and a great benefits package including but not only an annual bonus pension contribution family health insurance 27 days of annual leave access to BMS Cruiserath on-site gym and life assurance

#LI-Hybrid

If you come across a role that intrigues you but doesnt 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.

Supporting People with Disabilities

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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: Protection

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