Regulatory Compliance Expert: Manufacturing Operations

3 dagen geleden

Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

Company Overview

Bristol Myers Squibb is a leading global biopharma company with a long history of innovation in the pharmaceutical industry. With a strong commitment to research and development, we strive to create innovative medicines that transform patients' lives.

Salary Range: $150,000 - $200,000 per year

Job Description

The Senior Manager Compliance, MFG Compliance & Support will play a critical role in ensuring the quality and compliance of our manufacturing operations. This position will be responsible for managing Manufacturing Compliance & Support operations activities, including reviewing and implementing strategies to mitigate potential risks, improving quality record turnaround time, and ensuring on-time completion of MFG deviations, CAPAs, and CCs.

Key Responsibilities:

  • Identify, assess, and prioritize potential risks and implement strategies to mitigate their impact, for both compliance and safety.
  • Drive quality record turnaround time (TAT) improvements.
  • Accountable for on-time completion of MFG deviations, CAPAs, and CCs.
  • POC and representative for manufacturing in all applicable cross-functional local and global review boards.
  • Develop, manage, and report on manufacturing compliance KPIs.
  • Coordinates corrective actions with MFG operations and C&S technical training to imbed changes into routing operations training.
  • Responsible for level loading deviations throughout all C&S specialist in collaboration with C&S leadership team.
  • Accountable for manufacturing business continuity planning.
  • Leads and/or represents manufacturing for internal/external inspections.
  • Responsible for driving manufacturing inspection readiness.
  • Accountable for Aseptic Process Simulation life cycle management, execution, and reporting.
  • Accountable for on-time completion of effectiveness verifications of all CAPAs.

Technical Training

  • Coodinates required trainings for specialists to be qualified for quality record authoring and ownership. Front Line Support.
  • Accountable for receiving and processing all escalations and deviations generated from FLS.
  • Develops, manages, and reports on KPIs related to MFG operational execution throughout the MFG organization.

Qualifications & Experience

  • Minimum of 7 years of relevant manufacturing experience.
  • Minimum of 5 years leadership experiences including the management of direct reports required.
  • Minimum of 3 years in a Quality Assurance role managing deviations and CAPA.
  • Extensive knowledge of EOHSS, cGMPs and ATMPs regulations and principles.
  • Demonstrated proficiency in departmental organizational development.
  • Adaptable to a fast paced, complex, and dynamic business environment.
  • Knowledge of lean manufacturing principles.
  • Excellent communication skills.

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