CQV Project Manager
- United States
- Contract
- CAPEX Projects
Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a CQV Project Manager to help support operations at their Maryland facility.
With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
Responsibilities:
- Head up the active role in the implementation of recurrent coordination meetings, workshops and training during the project.
- Structure and consolidate key challenges in the project during the various phases for communication and escalation.
- Present project key issues/decision with strong story line and clear messaging during all phases. The target groups are the project management, the project governance, the program management.
- General facilitation of project and design decision processes through the phases.
- Plan, prepare, facilitate, and document workshops and other key project activities as appropriate.
- Run overall discussions and alignments when these occur, with the responsibility to solve any technical and management issues rising within Project Management.
- Take up the leading CQV role across the program.
- CQV PM responsible for the CQV Team and Deliverables from Concept Design through to successful PPQ Runs.
- Have valued into each Design Stage for Project, Concept, BOD and Detailed Design, ensuring at all times that all Quality and Compliance deliverables are included in Design.
- Build CQV Team from Day 1 on Project to ensure the Team is in place to deliver the project at each stage – Design, Document Generation, FAT, Mechanical Completion, Set to Work, PreSafety Start up Reviews, Commissioning, Qualification and full handover to Operations.
Experience:
- BS Engineering (or equivalent experience)
- 15+ years working CQV experience in the Pharmaceutical Industry (preferable in Biologics manufacturing)
- Exceptional teamwork abilities
- Strong knowledge of GMP’s, regulatory requirements
- Excellent written and verbal communication skills for both technical and non-technical audiences
If this role is of interest to you, please apply now!
#LI-AN1
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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