Quality Assurance Project Manager

The primary responsibility of this role is to manage product transfer related activities associated with the business unit activities including key manufacturing partnerships. Informally manage project teams to meet product transfer related deliverables and meet projected timelines need to commercialize. The incumbent serves as the single point of contact between the project team and customer. The incumbent will support directing of technical transfer, laboratory method transfer, master document creation, raw material release activities, QA release and oversight activities.
* Lead product transfer activities into production area as Project Manager
* Manage and control the development of each project's work scope, schedule, technical transfer, laboratory transfer, Quality compliance, safety compliance, budget requirements, and COGS alignment.
* Interface with internal and external resources to facilitate the transfer of process knowledge to the manufacturing environment.
* Ensure that all transfer activities adhere to cGMP, FDA, EU, and other applicable Quality Compliance requirements through leading the proper coordination and review by Quality Assurance.
* Participate in and sponsor Operational Excellence related activities to improve work processes related to project execution and ensure inclusion of OE concepts throughout execution by team members.
* Sponsor manufacturing efficiency by evaluating technical transfer to ensure selection of best practices for commercial manufacturing.
* Coordinate customer activities and ensure adequate customer service and response levels throughout the project team.

The selected candidate is required to possess the following:
* BS 6+ years or MS 2-4+ years or a PHD 0-2+ years of Pharmaceutical manufacturing experience.
* Minimum 10 Years equivalent work experience within the pharmaceutical industry.
* Professional registration and /or certifications as appropriate.

Background should include:
* Experience in pharmaceutical manufacturing, filling, and packaging preferred
* Experience with acting as the single point of contact between internal/ external customers and leading teams of professionals
* Experience as a Project Manager or significant experience as a team member
* Working knowledge of various regulatory agencies includes FDA, EU, OSHA, DOT, and EPA, and other governmental regulations which control the manufacture, transportation, or waste.

Special skills should include:
* Must have excellent written and verbal communication skills
* Computer processing skills are also necessary(MS Word, Excel, PowerPoint, and Project)
* Demonstrated team leadership skills
* A basic knowledge of business accounting/finance, marketing/advertising, material requirements/ planning and computer information systems is required.

To find out more about Real Staffing please visit www.realstaffing.com