Senior CQV Project Manager
Spokane, Washington, United States of America
Full Time
17 hours ago
$130,000 - $140,000 USD
Key skills
BIPower BILeadershipProject ManagementRisk ManagementCommunication
About this role
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Senior CQV Project Manager to join our team! Our CQV Project Managers provide end-to-end leadership and technical oversight across the full Commissioning, Qualification, and Validation (CQV) lifecycle. The Senior CQV Project Manager serves as a trusted advisor, leading project planning, strategic development, and execution for complex pharmaceutical and life sciences initiatives. This position requires strong technical expertise, disciplined project management, and the ability to effectively manage stakeholders, vendors, and cross-functional teams.
- Lead large‑scale, cross‑functional NPI and CQV projects from initiation through closeout within regulated pharmaceutical manufacturing environments.
- Develop, maintain, and execute integrated project plans, including scope definition, schedules, budgets, resource plans, and critical path analyses.
- Ensure project schedules accurately reflect scope, milestones, and interdependencies, and are routinely reviewed and updated.
- Provide end‑to‑end oversight of commissioning, qualification, and validation lifecycle activities using risk‑based methodologies.
- Apply cGMP, FDA, and global regulatory requirements to all project phases, ensuring compliance and inspection readiness.
- Facilitate alignment across Operations, Quality, Regulatory, Supply Chain, Engineering, and Commercial teams to drive timely execution.
- Serve as a primary point of contact for senior stakeholders, delivering clear communication on project status, risks, timelines, and financial performance.
- Support commercial objectives through KPI tracking, internal coordination, and contribution to scope development and proposal support as needed.
- Identify, assess, and proactively mitigate project risks; lead root cause analysis and corrective actions for issues impacting scope, schedule, or quality.
- Oversee vendors, contractors, and internal resources to ensure high‑quality, compliant deliverables.
- Lead resolution of technical, operational, and regulatory challenges encountered during NPI, CQV, and technology transfer activities.
- Drive continuous improvement by identifying opportunities to optimize NPI and CQV processes and contributing to PMO best practices.
- Mentor and support the development of junior project managers and project team members.
- Maintain compliance with GMP requirements, including working in aseptic and cleanroom environments as required, and supporting onsite activities throughout project execution.
Requirements
- Bachelor’s degree in Project Management, Engineering, Life Sciences, or a related technical discipline required (Master’s degree or MBA preferred).
- PMP certification required.
- 8+ years of project management experience within pharmaceutical, biotech, or other regulated manufacturing environments, including leadership of complex, cross‑functional initiatives.
- Hands‑on experience supporting Commissioning, Qualification, and Validation activities across the full CQV lifecycle.
- Proven success managing NPI, product launch, technology transfer, scale‑up, or site transfer initiatives.
- Strong working knowledge of cGMP regulations, FDA requirements, and global regulatory expectations.
- Experience working in aseptic manufacturing areas and cleanroom environments required.
- Advanced proficiency with project management tools and systems (e.g., MS Project, SharePoint, Power BI) and Microsoft Word for documentation and meeting records.
- Demonstrated expertise in risk management, budget control, scheduling, and stakeholder communication.
- Excellent analytical, problem‑solving, and organizational skills, with the ability to adapt to evolving project and site needs.
- Ability to work onsite as required.
- Must be authorized to work in the United States.
- No C2C at this time.