PHARMACEUTICAL – SR. CQV Manager/Lead

MMR Consulting • San Francisco, CA

9d • Onsite

About The Position

MMR Consulting is seeking a Sr. CQV Manager/Lead with previous Pharmaceutical/Biotech experience for Commissioning, Qualification & Validation in Pharmaceutical Manufacturing. This role requires 90% travel to various locations across the US. The successful candidate will join a growing team of engineers involved in the design, commissioning & qualification, start-up, and project management of various processes, systems, and facilities. The ideal candidate will possess leadership skills to lead teams of intermediate & junior engineers. This role will require leading commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. The individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes, ensuring compliance with FDA, cGMP, and global regulatory standards. Strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments is essential. The role serves as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This position requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.

Requirements

• Minimum 8–12 years of experience in pharmaceutical, biotech, or life sciences industries.
• Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.
• Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects.
• Strong experience with commissioning and qualification of: Cleanrooms, Process equipment, Utilities, Automation systems, Manufacturing processes.
• Experience authoring and reviewing validation lifecycle documentation.
• Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.
• Experience supporting FDA audits and regulatory inspections.
• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• Strong understanding of: cGMP regulations, FDA validation requirements, ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE, GAMP 5 principles.
• Proficiency with project management methodologies, scheduling tools, and reporting systems.
• Excellent communication, leadership, and stakeholder management skills.
• Ability to work effectively in fast-paced, highly regulated project environments.

Nice To Haves

• Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.
• Digital Validation software experience (i.e. Kneat or equivalent).
• PMP certification preferred.
• Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.
• Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
• Previous consulting or EPCM experience is a plus.
• Lean Six Sigma certification preferred.

Responsibilities

• Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
• Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
• Coordinate commissioning and qualification activities for: Process equipment, Clean utilities, HVAC systems, Automation and control systems, Manufacturing and packaging lines.
• Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
• Oversee execution of: FAT/SAT protocols, IQ/OQ/PQ protocols, Validation documentation, Deviations and CAPAs, Change controls.
• Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.
• Manage third-party CQV consultants, contractors, and vendors.
• Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.
• Support startup, operational readiness, and technology transfer activities.
• Present project status updates and KPI reporting to senior leadership and stakeholders.

Benefits

• Compensation: 120,000$ - 150,000$ based on experience.
• Equal Employment Opportunity and Reasonable Accommodations
• We celebrate diversity and are committed to creating an inclusive environment for all employees.
• Our hiring decisions are based on merit, qualifications, and business needs.
• We are committed to working with and providing reasonable accommodations to individuals with disabilities globally.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior