Project Manager - Lenoir, NC (REF7734L) Details

Project Manager - Lenoir, NC (REF7734L)

ProPharma Group - Lenoir, NC

Employment Type : Full-Time

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

This client is looking for a project manager/coordinator for the filtration and filling of their 2P. Experienced CQV Project Management who is familiar in an expansion environment is required. Technical Knowledge of filtration and filling is a plus, but not required. Position requires MS Project Experience, coordinating meetings, multi-client environment, tracking deliverables. The Project Manager will help coordinate the following efforts:

• Change control(s), shutdown coordination, cycle development, validations, SOPs and Work instructions
• Some Specific Activities PM may coordinate:
• Process Recipe Support
• Upload Vender Documentation
• Coordinate Work Order
• Manage Spare Parts
• Request Logbooks
• Coordinate Qualification Activities
• Execute Smoke Studies for Fill Room
• Update Maintenance Documentation
• Update Maintenance Documentation
• Update Operational Documentation
• Update Microbiologic Documentation and Procedures
• Update Drawings
• Update Yearly Equipment Re-Qualification Maintenance Validation Schedule (Form-000620)
• Evaluate VMP Documents (update as required)
• Verification
• Media Fill
• Backups
• Program Emergency Backups

Qualified candidates must have:

• Bachelor’s degree in health administration, business or related field.
• Preferred: Master’s in Business Administration
• Minimum of 3 to 5 years project management experience.
• Industry experience in pharmaceuticals, healthcare or related business.
• Experience in operations, quality, project management, or related fields.
• International work experience a meaningful plus.
• Ability to facilitate and lead cross-functional meetings with C-level participants and subject matter experts.
• Strong analytical and presentation skills.
• Excellent written and oral communication skills.
• Detail-oriented, conscientious and extremely well organized.
• Ability to exercise considerable judgment, maintain confidentiality, and act in a diplomatic manner.
• Ability to manage multiple competing priorities.
• Ability to work extended hours, weekends, and holidays pursuant to industry demands.
• Willingness to travel.

All candidates must be legally eligible to work in the United States.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***