iSixSigma

Compliance Manager, Cell Therapy Manufacturing

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Bristol-Myers Squibb
Published
February 5, 2021
Location
Devens, MA
Job Type

Description

BMS Cell Therapy Manufacturing seeks a Compliance Manager who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support quality systems and department training needs.

DUTIES AND RESPONSIBILITIES:

  • Develop internal controls and policies designed to ensure that all compliance needs are met
  • Develop training content and curriculum for all Manufacturing Operations
  • Work closely with department managers to review all departmental policies for compliance issues
  • Accountable for ensuring full quality and regulatory compliance of Manufacturing GMP operations.
  • Accountable for ensuring department personnel are updated on relevant procedures to ensure adequate compliance with
  • Develop and deploy training material to support manufacturing associate learning
  • Work as a liaison between manufacturing and Quality Operation and relevant Management systems.
  • Serve as a resource for Tech Transfer activities · The ability to lead and train manufacturing teams to review manufacturing batch records, testing data, SOPs, Deviations, Change Controls, and Corrective and Preventative Action (CAPA).
  • Assist with Tech Transfer and Manufacturing Risk Assessment and Mitigation evaluation activities.
  • Responsible for reviewing qualification and re-qualification of manufacturing related equipment and facility as the operations representative
  • Guides functional team to complete protocols, reports and SOPs and have the knowledge base to review and authorize documents as the manufacturing representative in the absence of Senior Management
  • Communicates to all functional area managers and supervisor Quality related initiatives and actions.
  • Must be familiar with many GMP-related aspects and systems like:
  • Quality Risk Management
  • Document and Data Governance
  • Monitoring and Quality Reports
  • Must have the ability to challenge and make recommendations
  • Escalate compliance concerns to management in a timely manner
  • The ability to review and approve change controls as the manufacturing representative
  • The ability to work as the functional area approver and reviewer · Maintain CAPA databases and Investigations and prepare trend reports
  • The ability to follow-up on CAPA completion timelines pertaining to deviation, OOS, EM and audits
  • Work in conjunction with senior management to establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
  • Ensure high levels of communication with team, support resources and management regarding issue identification and resolution
  • Evaluate functional strengths and developmental areas a team with the ability to focused on continuous improvement as it relates to compliance
  • Other duties as assigned

REQUIRED COMPETENCIES:

Education:

  • Bachelor’s Degree

Experience

  • 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
  • 5+ years in a Manufacturing/Operations in a cGMP environment is required
  • Ability to lead investigations when needed by leveraging six sigma tools
  • Ability to work by influencing peers and their reports and gain their cooperation.
  • A high sense of urgency and a commitment to delivering results is essential.
  • Cell Therapy manufacturing experience preferred.
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