Manufacturing Support Project Manager

Raleigh, USA

The Manufacturing Support Project Manager will manage and ensure smooth execution of assigned manufacturing support projects, including facility startup, process lifecycle and tech-transfer projects from initiation to execution, in order to ensure timely supply to the markets in compliance with regulatory and cGMP requirements.

Published on December 13, 2019

PROJECT MANAGEMENT:

  • Help build and maintain the overall product lifecycle management project plan to reflect site, department, and team goals
  • Ensure project progress is integrated and communicated to other key Project Leads and Corporate Development VPs in support of company objectives
  • Drive overall adherence to planned timelines
  • Work closely with task owners to identify requirements and needs
  • Influence participants and stakeholders without authority

CHANGE CONTROL:

  • Initiate and manage change control records to support GMP manufacturing process changes
  • Present process change control proposals to the change control review board
  • Work in close collaboration with other Change Control members for identification, evaluation and implementation of change control records (Change Coordinator, Manufacturing, QA, Regulatory, Process Development, MS&T, QC, Supply Chain, Planning, etc.)
  • Coordinate and contribute to impact assessments for change controls
  • Participate in planning of CAPA as they relate to Change Control requirements
  • Contribute to the Asset Change Control process as it relates to Product/Process Change Control requirements
  • Serve as subject matter expert for the change control system, processes and procedures

ANNUAL PRODUCT REVIEW/PRODUCT QUALITY REVIEW (APR/PQR):

  • Compile and review the PQR data for Product Change Control and provide discussion sections

PROCESS IMPROVEMENTS:

  • Identify and implement improvements for process, operations, and quality, relating to product lifecycle management

TRAINING:

  • Own the Training Curriculum for this Job Profile and provide the necessary support to new associates joining in similar roles

AUDIT SUPPORT:

  • Maintain the product lifecycle management processes at inspection-readiness level and to provide the necessary support in any internal or external audit

QUALIFICATIONS & EXPERIENCE:

  • Bachelor’s in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree required. Master’s degree preferred
  • Minimum 3 years experience in GMP manufacturing role on the shop floor and/or MFG Support/QA/QC.
  • GMP Quality Systems experience, including Change Control and Deviation Management
  • Proven process understanding (i.e. Pharma, GMP, Regulatory aspects).
  • Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus
  • Fluent in English