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
- Bachelor’s Degree
- 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.