Project Manager - Senior CQV Pharmaceutical

Details:


Introduction
Visium Resources has been asked to recruit a Senior CQV Capital Pharmaceutical Project Manager for our client's growing team. The successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The work will require working out of the client's facilities Thousand Oaks, California.

We are seeking an experienced Project Manager - Capital projects leader with a strong background in engineering or scientific disciplines and proven delivery experience within the pharmaceutical or biotech industry. This role is responsible for leading complex, cross-functional CAPEX projects (manufacturing, laboratories, utilities, engineering, construction) utilizing the best PMO standards, governance, and execution discipline.

This is a hands-on leadership role requiring ownership of project outcomes, stakeholder alignment, and technical understanding of regulated environments.

Responsibilities

Project Leadership & Delivery

• Lead end-to-end execution of capital projects, within pharmaceutical manufacturing and laboratories, from inception / business case development, through to project execution and closure.
• Manage many projects simultaneously (typically three to four), typically ranging between $1-10M, but the actual values may fluctuate (sometimes there are larger projects).
• Manage scope, schedule, cost, and quality across multiple concurrent projects, provide regular status updates & reporting on projects
• Drive project planning (charters, schedules, resource plans) and ensure realistic execution strategies
• Identify risks early and proactively manage mitigation plans in regulated environments. Escalate & resolve issues proactively.
• Document, manage and monitor action items, issues, decisions, risks.

PMO Governance & Standards

• Utilize world class PMO best practices, tools, and reporting structures for executing capital projects
• Work with project controls specialists on schedule tracking, cost forecasting, change management.
• Lead stage-gate processes aligned with GMP and validation requirements
• Provide portfolio-level visibility to leadership (KPIs, dashboards, resource loading)

Cross-Functional Coordination

• Requires interfacing / managing many stakeholders including engineering, construction, manufacturing, EHS, IT, QA, QC, Regulatory, maintenance, calibration, in a high paced manufacturing environment.
• Act as the central point of coordination between internal stakeholders and external vendors/contractors
• Manage third-party engineering firms, system integrators, and construction partners

Regulatory & Compliance

• Ensure projects align with U.S. Food and Drug Administration expectations and GMP requirements
• Oversee validation lifecycle activities (IQ/OQ/PQ), commissioning, and documentation readiness
• Maintain audit-ready project documentation

Stakeholder Management

• Communicate effectively with senior leadership and site-level teams
• Translate technical issues into business impacts and actionable decisions
• Drive accountability across teams without direct authority

Job Requirements

Minimum Security Clearance:


No Clearance


Details:


Qualifications

Education

• Bachelor's degree in Engineering, Life Sciences, Scientific or related field
• Advanced degree (MBA, MS) is a plus

Certifications (Preferred, but not required)

• PMP (Project Management Professional) - Project Management Institute

Experience

• 8-15+ years of project management experience
• 5+ years within pharmaceutical, biotech, or life sciences environments
• Demonstrated experience delivering capital projects, validation, manufacturing or compliance initiatives
• Experience working within or alongside a formal PMO

Technical & Industry Knowledge

• Strong understanding of GMP, validation, and regulated project environments
• Familiarity with systems such as MES, LIMS, ERP (e.g., SAP), or automation platforms is highly desirable, but not required.
• Experience with engineering design, construction, or process scale-up is highly desirable, but not required.

Core Competencies

• Strong execution mindset (not just reporting)
• Ability to manage ambiguity and drive decisions
• High accountability and ownership of outcomes
• Commercial awareness (cost, ROI, timelines)
• Ability to challenge stakeholders constructively
• Multi-tasking, escalating, reporting, tracking, documentation
• Working in a fast-paced environment in a large organization

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.

Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.