Quality Operations Project Manager

Manpower is now recruiting for one of our clients on a temporary basis for a Quality Operations Project Manager. A new position of Quality Operations Project Manager has arisen to support the External Manufacturing Quality team, due to the insourcing of newly acquired acquisition clinical trials.

Role: Quality Operations Project Manager
Location: Moreton (CH46)
Pay: £20ph
Duration: 12 months
Hours: Monday - Friday (35 hours a week)

Job Summary
Product Development Quality (PDQ) Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with GMP and other applicable regulations and internal procedures.

Job Description
Serves as Project Manager for prioritising and alignment of external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organisations (CMOs).
Partner with Regulatory Affairs and Global Clinical Supply Chain to ensure on-time delivery of Health Authority approvals for release of clinical supplies (as applicable).

Desired Candidate Characteristics:?

• Ability to understand the needs of the business and commitment to deliver efficiency
  
• Able to collaborate across multiple teams??
  
• Excellent communication skills?
  
• Innovative and inquisitive nature to ask questions
  
• Ability to learn new tools and processes?
  
• Excellent organisation and time management skills
  
  Key Responsibilities
  
• Project Manage/support the External QP release process.
  
• Co-ordinate/align on all required documentation.
  
• Triage/answer any QP related queries.
  
• Liaise with Trials Supplies Management (TSM), Trial Managers (TM), Regulatory CMC QA, Regulatory Affairs, and Product Development Quality.
  
• Identify dependencies, evaluate risks, and communicate status to appropriate levels of management and stakeholders across the business.
  
• Ensure project deliverable and schedules are met, adhere to established standards, which are managed in alignment with the clients Project Management best practices across their assigned projects.
  
• Proactively remove obstacles to drive assigned project's momentum and progress
  
• Plan and engage necessary resources across the enterprise to ensure successful completion of assigned projects.
  
• Advise and consistently apply Project Management best practices and tools.
  
  Qualifications & Experience
  
• Degree qualified or equivalent experience required.
  
• Project Management experience is essential.
  
• Previous Pharmaceutical Quality experience is desired/preferred.
  
• Demonstrated experience leading initiatives related to continuous improvement and/or implementation of new ways of working.
  
• Demonstrated ability to build and leverage relationships through diplomacy with a broader focus?within the Function.
  
• Experienced in process improvement.
  
• Ability to recognise the potential impact on internal/external challenges on the future state success.
  
• Good knowledge/experience in computer systems (MS, excel, word, etc.).
  
• Ability to co-ordinate/lead meetings.
  
• Knowledge of clinical trial documentation submission and approval preferred.
  
  Apply now for immediate consideration