GMP Project Implementation Manager

GMP Quality Project Implementation Manager – (Contract) – 2.5 Months – Onsite – KY

Biotechnology Research Company seeks a Project Implementation Manager to work with Corporate/Site Quality Teams, in addition to Manufacturing, Technical, Engineering and Commercial as needed. This person will be accountable for a project portfolio involving new production and testing, product transfers, customer qualifications and support as well as internal process improvements, and compliance related programs. Individual will coordinate internal resources and vendors for the development, planning and execution of projects ensuring on time delivery, project is within scope and delivered within the budget within regulatory environments like cGMP, ICHQ7, ISO, IPEC and FDA. Opportunity offers 1099 consultant a short-term project that could go longer, onsite in KY. Local candidates only please.

Requirements

• 5+ years Project Management in Life Sciences, with a focus on Quality and regulatory compliance within cGMP environment within chemical, pharma, or biotech organizations.
• Expertise leading projects from beginning throughout delivery.
• Strong history of working in GMP and ISO9000, as well as ISO, FDA including 210/211 Part 11.
• Expertise managing projects and programs throughout delivery.
• Ability to travel up to 30% and be onsite in northeastern Lexington KY.
  
  

Responsibilities

• Collaborating with stakeholders internally and externally in the development and planning of project scopes and objectives.
• Developing detailed plans to track progress, while monitoring progress and ensuring successful project delivery.
• Measuring project performance with appropriate tools, systems and techniques while entering project-related detail into software tracking systems.
• Communication of project challenges and roadblocks to senior leadership throughout, escalating accordingly.
• Scheduling, organizing and leading team meetings to assess progress against functional task lists/timelines.
• Ensuring effective preparation and delivery of project events and meetings, while also ensuring production of necessary documentation is executed in excellence throughout each phase.
• Assisting teams prior to the tollgate/milestone meetings to ensure readiness to proceed with next phase of project; participating and leading these meetings as well.
• Leading root/cause/countermeasure processes to mitigate any quality, scope, or budgeting issues, and ensure projects remain on track.
• Performing additional duties as needed.