Project Manager, Quality

Permanent
Attention! This job posting is 277 days old and might be already filled.
Salary
Highly Competitive + relocation
Location
Mid-West, United Kingdom
Category
Pharmaceuticals

Description

Manages all aspects of complex projects within Quality Control and Quality Assurance functions from inception to conclusion.  Coordinates efforts to ensure progress on critical activities and measures milestone achievement to prepare site to begin laboratory services required to support all related production and testing activities.  Works with internal and external stakeholders to ensure project activities are progressing according to project plan timeline.

Key Responsibilities

  • Coordinates with QC/QA management, global functions, and SME’s to build plans related to procurement, commissioning and qualification activities, budgeting, and service delivery commitments
  • As the point of contact on assigned projects related to laboratory services readiness, performs a variety of highly skilled duties such as: assembling, coordinating and managing multidisciplinary technical review teams
  • Designs QC Project Plan and recommends resource management approach and budgetary requirements
  • Oversees progress on equipment purchasing and installation
  • Ensures specification and documentation requirements are met
  • Engages directly with vendors/contractors during RFP activities and to evaluate supplier capabilities
  • Facilitates and troubleshoots the myriad of problems associated with developing complex systems or with coordinating and development, and design projects
  • Responds to inquiries about projects and provides coordinating support to QA leadership and program management resources
  • Chairs various project review and vendor evaluation meetings
  • Establishes and maintains liaison as required with stakeholders, vendors, and external parties
  • Coordinates schedules of required personnel and other interested parties to support key activities
  • Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations.   Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination
  • Document all work performed according to applicable Current Good Documentation Practices and CGLP’s
  • Manage and escalate Quality issues to the Director of Quality and relevant Leadership Team members

 

 

Candidate Requirements

  • Requires a B.S. Degree in Management, Life Science, or other related scientific discipline or at least 10 years of equivalent experience in a manufacturing management or project management role
  • Candidate  must possess competent written and oral communication skills and organizational abilities
  • Prior experience with clean room production and/or CGMP production environment is preferred
  • Knowledge of Microsoft Project software application preferred
  • Project Management Certification or equivalent experience preferred
  • Knowledge of sterile manufacturing or aseptic filling preferred
For more info contact: David Potter
Email Address: david.potter@conciliumsearch.com
Contact Number: +44 (0) 753 973 7331
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