Senior CQV Project Manager

PM Group; Apex (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Join a dynamic and innovative team as a Senior CQV Project Manager in Apex, NC, where you will play a pivotal role in executing cutting-edge projects for the pharmaceutical and biotech industries. This is an exceptional opportunity to leverage your extensive experience in commissioning, qualification, and validation while leading diverse teams to deliver high-quality results for clients. You'll be at the forefront of projects that enhance lives globally, working collaboratively with clients and colleagues alike. If you are passionate about driving excellence in project delivery and thrive in a fast-paced environment, this role is perfect for you.

Qualifications

• 10+ years of CQV experience in CGMP Pharmaceutical and Life Sciences.
• Strong commercial awareness and business acumen required.
• Ability to lead teams and manage multiple projects simultaneously.

Responsibilities

• Lead multiple CQV projects ensuring timely and budget-conscious delivery.
• Develop and maintain strong customer relationships and communication.
• Ensure compliance with regulatory authorities and internal procedures.

Skills

Project Management

Client Interaction

Technical Documentation

Team Leadership

Communication Skills

Problem Solving

Education

Bachelor’s Degree

Engineering Degree

Tools

Earned Value Management Systems

Agile Project Management

Job description

Overview

The Senior CQV Project Manager position is an exciting opportunity to join PM Group’s quickly growing Raleigh-Durham, North Carolina area team in Apex, NC. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. Our office is executing cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities – from feasibility through qualification – for both local and international clients. With our clients and partners, we will deliver projects that improve the everyday lives of people across the globe.

This is a senior level career position and we are looking for a professional who enjoys client interaction as well as the technical aspects of the position. This position requires an understanding of the technical aspects of commissioning (Cx), qualification and validation (CQV). The ability to successfully handle multiple real-time complex projects while maintaining a strong work ethic, and drive to deliver for clients, as a collaborative colleague, is necessary for this role. Understanding and applying the principals of good documentation practices (CGDP) is essential to performing in this position. The CQV Sr. Project Manager is mentored by more senior level CQV team members, provides guidance to less experienced CQV staff, and will report to the Director of CQV. Their responsibilities will include project leadership, project team leadership, developing and maintaining good Customer relationships, document development, document review and approval, oversight of testing execution, and ensuring successful delivery of Customer projects within scope, schedule and budget. Expect project work to include all levels of qualification from design to completion. Project sizes will vary and the duties of the role require periodic travel to client sites.

Responsibilities

• Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
• Ensure safe execution of all project deliverables
• Overall responsibility for the CQV technical/commercial delivery and project execution and project leadership
• Simultaneously lead multiple CQV projects, teams, cross-functional teams and technology transfer teams to successfully deliver projects within scope, schedule and budget; coordinating CQV activities between all disciplines
• Develop project proposals based on client RFPs identifying CQV resource needs, equipment, staff and timelines
• Develop and maintain good Customer relationships and set up appropriate communications and reporting structures (meetings, reports etc.)
• Develop project execution strategies including resource needs and schedules in alignment with Project Teams and Customers expectations
• Independently assess the qualification needs of equipment, facilities, utilities, and systems while tracking progress on all Customer complaints and implementing controls to mitigate risk
• Lead the proposal effort: develop the execution strategy, commercials for proposal and lead the presentation to the Client
• Monitor project execution strategy effectiveness, and scope deliverables to prevent scope creep
• Obtain POs from the Client; Determine the need for Change Orders; agree to invoicing details; track payments
• Prepare Project Monthly Internal Report (PMIR) for PM Group Management and ensure early notification of any significant project issues with potential commercial risks
• Prepare project reports for Customers (weekly/monthly or otherwise as required by the Customer or as appropriate to the project), covering Health Safety and Environmental, project progress (achieved and planned), cost and schedule status, ensuring visibility of key project risks, trends and areas of concern
• Close out of projects including certification, handover, close-out review / report, project metrics, capturing “Lessons Learned” and filing/archiving
• Ensure compliance with regulatory authorities, PM Group and Customer procedures
• Lead factory site acceptance testing (FAT) and site acceptance testing (SAT) activities
• Oversee commissioning pre-functional checklist (PFC) development, and commissioning functional performance testing (FPT) activities
• Proactively assist in determining client needs related to the development of user requirements specifications (URS)
• Perform system impact analysis (SIA) and develop tractability matrices
• Perform facility CGMP Design Reviews
• Manage the validation change control process and lead the document review and approval process
• Ensure the implementation of current good manufacturing practices (CGMP), good engineering practices (GEP) including documentation practices (GDP)
• Provide technical guidance to less experienced CQV team members
• Special projects as assigned

Qualifications

• Bachelor’s degree is required; an engineering degree is preferred
• 10+ Years of CQV experience in CGMP Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries
• Experience managing large and small CQV projects
• Good commercial awareness and business acumen
• Strong work ethic, self-driven, results-oriented with a positive outlook, and a clear focus on high quality
• A forward planner who identifies and resolves project issues
• Ability to critically assess own performance and the performance of others
• Thorough understanding of current good engineering practices (GEP) and CGMP
• Understanding of earned value management systems; PMP and or Agile Project Management certification is preferred
• Demonstrated excellent team leadership skills
• Excellent verbal communication, written communication, technical report writing, presentation skills and the ability to author technical and scientific reports
• Fluent in the review of basic design drawings
• The ability to travel as needed for client development and project execution

All of your information is confidential according to EEO guidelines.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Health, Safety & Well-being Report 2022.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

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