Senior Specialist, Quality Compliance

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

This role is a 12 month Fixed-Term Contract role.

The Role

The Quality Compliance Senior Specialist is responsible for implementing supporting and monitoring of the effectiveness of the Quality Systems within the Global External Manufacturing organization.

Key Duties and Responsibilities:

Quality Management Systems

• The Quality Compliance Senior Specialist will carry out duties relevant to Quality Management Systems processes within Global External Manufacturing.
  • Carry out Quality Systems duties relevant to 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
  • Support subject matter expert for review of regulatory or directive changes.
  • Regularly review the process (trends metrics trends observations RFT Design waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
  • Carry out activities to implement Health Authority commitments related to the process
  • Support the subject matter expert in audits / inspections
  • Participate in pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements regulatory surveillance

Processes include Deviation Investigations CAPA complaints change control Quality Risk Management Documentation and Records Management Audits and Inspections Supplier Management. Mock Recall Regulatory Surveillance and Data Integrity.

Support 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 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 documents
• Maintain the system and process for record management
• Maintain the system for update of ExM GxP Authorizations
• Act as facilitator and reviewer of Quality System Framework updates
• Act as ExM Quality 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 owned processes
• Act as qualified trainer for Quality Systems owned processes.

There will be 5% travel associated with this role.

QualificationsKnowledge and Skills Required:

Required

• A science related degree in Chemistry Engineering or Biotechnology
• A minimum of 3 years experience in a pharmaceutical Quality related role preferably within a Quality Systems team.
• A strong working knowledge of GxP regulations in the EU US and other relevant global markets
• Knowledge of OPEX tools
• Experience in leading or participation in project teams

Desirable

• Experience in a GxP Manufacturing site
• Technical writing training / qualification
• Lead investigator training
• Qualified auditor
• Lean Six Sigma qualification
• Project Management qualification

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 work load
• Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
• Fluent English is required.

• 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.

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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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