Project Manager in San Diego

About the role

The Project Manager (PM) is responsible for overall management of scope, schedule, and budget on CAPEX and cGMP-compliance projects to FDA & EU regulated Advanced Therapeutic industries. This role is responsible for planning and overseeing projects to ensure they are completed in a timely fashion and within budget, managing project delivery by closely aligning with client stakeholders and advocating for their project success.

Responsibilities

• Lead business process mapping sessions with site stakeholders to create roadmaps to CAPEX project solutions for personnel, equipment, facility, data, and quality.
• Manages Architect/Engineer, Design-Build, Design-Assist, General Contractor and Commissioning and Qualification teams throughout project execution.
• Directs construction administration processes with engineer of record including RFI’s, submittals, change orders, field observations, punch lists, turnover packages, and closeout documentation.
• Applies knowledge and experience of facility programming, space planning, GMP material/personnel flows, cleanroom design principals, and operational requirements.
• Predicts, plans and resolves common design decisions that balance operational, quality, regulatory, schedule, budget, and constructability considerations.
• Responsible for overall scope, schedule, budget and risk management against contracts.
• Leads formal design review workshops at Conceptual, Basis of Design, 30%, 60%, 90%, IFC, and construction phases.
• Leads the process, tracking and controls for generation of project management documentation.
• Reports progress against deliverables and earned value using cost performance index CPI.
• Manages the successful execution of projects using cGMPnow standard tools and templates, client procedures and industry best practices to the agreed upon scope, schedule, budget and technical quality.
• Provides oversight of design packages and specifications, RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions.
• Maintains project budgets and schedules for trends/compliance to budget and prepare periodic reports.
• Coordinates reviews and checking of engineering deliverables.
• Coordinates the efforts of engineering support groups and external resources such as vendors, consultants and contractors.
• Conducts project meetings with user group and project stakeholders.
• Prepares detailed project cost estimates and schedules.
• Supports project closeout activities including punch list management, turnover documentation review, as-built documentation verification, and lessons learned sessions.
• Business Development:
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Shares with project PM potential opportunities observed for marketing services to clients and consistently maintain client contact.
• Supports preparation of detailed project cost estimates and schedules.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.

Requirements

• Must have excellent planning skills, be highly organized and detail oriented, able to manage multiple projects simultaneously and be able to adapt to changing environments and priorities.
• Must be a self-starter with the ability to work productively and meet benchmarks and goals in a timely fashion.
• Strong interpersonal communication and organizational skills are required.
• Experience in consulting firms strongly preferred.
• Project Management Professional (PMP) certification is preferred.

Qualifications

• Bachelor of Science Degree in Engineering, science, or closely related discipline.
• 10+ years total experience in GMP-regulated industry leading client-side project execution as a CAPEX Project Manager, Design Manager, Construction Manager, or similar role.
• 5+ years of experience managing CAPEX, cGMP-compliance and/or Operational Readiness projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (Advanced Therapeutics Preferred).
• Experience with managing A/E firms, EPCM firms, General Contractors and Commissioning & Qualification contractors.
• Experience with design management and governance.
• Experience leading Design review.
• Experience with construction administration and field oversight.
• Experience with cross-functional stakeholder alignment.
• Experience with consensus building and decision-making related to facility operations GMP compliance, and user requirements.
• Working knowledge of cGMP compliance.
• Strong knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements.
• Must be comfortable working in Client facilities and remotely.
• Proficient in project scheduling tools.
• Proficient in project controls tools and software.
• Proficient in Google Suite spreadsheet and word processing software.
• Demonstrated ability to communicate and work with staff at all levels.
• Able to work in the US without sponsorship now or any time or in the future.