Operational Readiness Project Manager
$140k - $175k/yr
Mid, Senior, Expert
Bachelor's, Master's
Boston, MA, USA+4 moreMore locations: Indianapolis, IN, USA | San Francisco, CA, USA | Raleigh, NC, USA | Philadelphia, PA, USA
HybridDomestic and international travel may be required.
Project & Program ManagementProgram Management
No H1B Sponsorship
About the job
Requirements
- A BS or MS in a relevant science or engineering field, or equivalent experience.
- At least 3 years as a program or project manager on life sciences projects valued at $1 million or more, or at least 8 years in Good Manufacturing Practice-regulated operations with at least 5 years leading readiness, start-up, or operational excellence transformations.
- Proven multi-site or multi-client portfolio experience.
- Deep understanding of quality systems, technology transfer, equipment qualification, and analytics.
- Excellent written and verbal English communication.
- Proficiency with project management software tools.
- Ability to work in the United States without sponsorship now or in the future.
- Willingness to work overtime when necessary.
- Domestic and international travel may be required.
Responsibilities
- Lead project teams to achieve Operational Readiness objectives.
- Manage the 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 Operational Readiness campaigns integrating with Quality, Process, and Workforce streams.
- Apply Operational Excellence principles to pre-Day One activities, including visual management, accountability, and problem-solving.
- Advise executive stakeholders, including vice presidents and site heads.
- Guide decision-making with a risk-based, speed-to-value mindset.
- Lead and coach cross-functional teams, including commissioning, qualification, and validation; Quality; and external contractors.
- Cultivate a culture of feedback and growth.
- Contribute to CAI's brand through white papers, conference presentations, and client tools.
- Align project stakeholders with a clear vision and measurable goals.
- Provide guidance for site and department leadership.
- Manage scheduling, resource loading, controls, and closeout.
- Execute comprehensive project planning and delivery.
- Drive site-wide transformation using Lean, Six Sigma, or Total Productive Maintenance methodologies.
- Evaluate initiatives, opportunities, and priorities based on fit with organizational strategies.
- Identify innovative solutions to challenges with strategic impact while balancing short- and long-term concerns.
- Identify issues related to emerging customer and market needs.
- Identify and anticipate customer requirements, expectations, and needs.
- Develop solutions that meet or exceed customer expectations and share feedback with relevant groups.
- Follow up with customers to resolve issues and maintain customer satisfaction and loyalty.
- Identify ways to improve customer service, including removing barriers and providing solutions.
- Translate business or functional strategies into aligned plans and objectives and integrate plans across business groups.
- Obtain and allocate resources needed to accomplish goals.
- Anticipate risk and build effective contingency plans.
- Prioritize and balance time, actions, resources, and initiatives to achieve critical goals.
- Hold self and others accountable for achieving outcomes.
- Anticipate obstacles and take appropriate actions to accelerate work or improve quality.
- Communicate information clearly, concisely, and professionally, adapting style and content to the audience.
- Write technical concepts clearly and thoroughly for different audience types.
- Cultivate a network across disciplines and functions within the organization.
- Build collaboration by identifying and conveying common interests and priorities, removing barriers, and breaking down silos.
- Involve others appropriately in decisions and plans that affect them.
- Maintain positive relationships across challenges, organizational levels, personalities, and backgrounds.
- Develop and articulate compelling rationales for positions.
- Build support among key decision-makers and influencers.
- Position and explain ideas and proposals to gain support.
- Encourage others to find solutions that improve outcomes and deliver value.
- Continuously develop interpersonal skills to build effective internal and external relationships.
- Model company values and act with integrity.
- Look for opportunities to develop breakthrough ideas and initiatives.
Desired Qualifications
- A Black Belt or equivalent qualification is preferred.
- PMI Project Management Professional (PMP) or Program Management Professional (PgMP) certification is a plus.
About the company
CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.
Company Size
1,001-5,000
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Indianapolis, Indiana
Founded
1996
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Simplify's Take
What believers are saying
- CAI closed its JLL recapitalization on July 1, 2026, funding acquisitions and technology.
- CAI expanded Australia hiring in Melbourne and Brisbane during 2026.
- CAI grew past 850 employees worldwide, signaling sustained demand for CQV services.
What critics are saying
- JLL Partners owns CAI after July 1, 2026 recapitalization, forcing exit pressure.
- CAI depends on regulated-industry capital spending; project delays hit utilization fast.
- Integrated rivals like Jacobs and Thermo Fisher target the same validation and readiness work.
What makes CAI unique
- CAI specializes in CQV for FDA-regulated and mission-critical facilities since 1996.
- CAI spans life sciences, data centers, and process manufacturing across North America, Europe, Australia, Asia.
- CAI pairs consulting with turnkey partnerships like Fedegari for sterilization implementation.
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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