Operational Readiness Project Manager at CAI

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life Sciences, BiotechnologyIndustries

Requirements

BS or MS in a relevant science or engineering field (or equivalent)
3+ years as a program/project manager on life science projects ($1MM+), or 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/OE transformations (Black Belt or equivalent preferred)
Proven multi-site or multi-client portfolio experience
Deep understanding of quality systems, tech transfer, equipment qualification, and analytics
Excellent communication, leadership, and stakeholder management skills
Proficient in project management software tools
Excellent written and verbal English communication
Able to work in the U.S. without sponsorship now or in the future
Willingness to travel domestically and internationally as required
Willing to work overtime when necessary
PMI PMP or PgMP certification a plus
Skills in consulting & facilitation (align project stakeholders with clear vision and measurable goals; expert-level guidance for site and department leadership)
Skills in project execution (manage scheduling, resource loading, controls, and closeout; execute comprehensive project planning and delivery)
Skills in continuous improvement (drive site-wide transformation using Lean, Six Sigma, or TPM methodologies)
Critical competencies: Influence Strategy (evaluates and pursues initiatives based on organizational strategies; identifies innovative solutions balancing short- and long-term concerns; identifies emerging customer/market needs); Satisfy the Customer (identifies and anticipates customer needs)

Responsibilities

Lead project teams to achieve Operational Readiness (OR) objectives
Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously
Drive on-time, on-scope delivery of readiness programs
Serve as the primary consultant for OR campaigns integrating with Quality, Process, and Workforce streams
Apply OE principles to pre-Day One activities (e.g., visual management, accountability, problem-solving)
Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.)
Guide decision-making with a risk-based, speed-to-value mindset
Lead and coach cross-functional teams including CQV, Quality, and external contractors
Cultivate a culture of feedback and growth
Contribute to CAI's brand via white papers, conference presentations, and client tools

Skills

Key technologies and capabilities for this role

Project ManagementProgram ManagementOperational ReadinessOperational ExcellenceFDA ComplianceVisual ManagementProblem SolvingStakeholder ManagementTeam LeadershipClient ConsultingQuality ManagementProcess Optimization

Questions & Answers

Common questions about this position

What salary is offered for the Operational Readiness Project Manager role?

This information is not specified in the job description.

Is this Operational Readiness Project Manager position remote or office-based?

This information is not specified in the job description.

What skills are required for the Operational Readiness Project Manager position?

Required skills include consulting and facilitation to align stakeholders, project execution for managing scheduling and delivery, and continuous improvement using Lean, Six Sigma, or TPM methodologies.

What is the company culture like at CAI?

CAI embraces a Team Before Self mindset, demonstrates Respect for Others, and maintains a Can-Do Attitude as core values, with a commitment to foundational principles like acting with integrity, serving each other and society, and working for the future under 100% employee ownership.

What qualifications make a strong candidate for this role?

Strong candidates have a BS or MS in a relevant science or engineering field, plus either 3+ years as a program/project manager on life science projects ($1MM+), or 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up.

CAI

Consulting for operational readiness in healthcare

About CAI

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Overland Park, KansasHeadquarters

1996Year Founded

$3.4MTotal Funding

PRE_SEEDCompany Stage

Industrial & Manufacturing, Biotechnology, HealthcareIndustries

1-10Employees

Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country

Risks

Competition from specialized firms in digital transformation may erode CAI's market share.

In-house consulting teams in corporations could reduce demand for CAI's services.

Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.

Differentiation

CAI offers comprehensive consulting services across multiple industries, including life sciences.

Their expertise in energy management aligns with the sustainability focus of data centers.

CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.

Upsides

Demand for digital transformation in life sciences boosts CAI's automation consulting services.

Personalized medicine trends create opportunities for flexible manufacturing process consulting.

Data centers' focus on energy efficiency aligns with CAI's energy management expertise.

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