Consultant, PAI Inspection Readiness

COMPANY DESCRIPTION

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with Bio Space's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

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We are seeking a Consultant, PAI Inspection Readiness to partner directly with the Quality organization in leading site-wide inspection readiness strategy and execution. This individual will provide full-time program leadership, coordinating cross-functional inspection readiness and Pre-Approval Inspection (PAI) activities across Quality, Manufacturing, Technical Operations, Engineering, Validation, Supply Chain, Regulatory Affairs, and other key stakeholders to ensure sustained readiness for FDA and global regulatory inspections.

This role requires a highly visible leader who can effectively drive alignment, accountability, and execution across multiple functional organizations. The successful candidate will be responsible for developing and maintaining inspection readiness programs, supporting mock inspections, identifying compliance risks, tracking remediation activities, and ensuring organizational preparedness for regulatory interactions.

The ideal candidate is a strategic yet hands-on leader with demonstrated success guiding pharmaceutical or biotechnology organizations through Phase III clinical development, commercial launch readiness, Pre-Approval Inspections (PAIs), and global regulatory inspections. Experience supporting drug-device combination products is strongly preferred.

This is a hybrid position requiring a significant onsite presence to effectively facilitate cross-functional planning, readiness assessments, mock inspections, and inspection support activities. Travel may be required based on business needs and regulatory inspection requirements.

(This list is not exhaustive and may be supplemented or adjusted as necessary.)

• Lead the development, implementation, and continuous improvement of the organization's inspection readiness strategy and program.
• Serve as the primary project manager for Pre-Approval Inspection (PAI) readiness and regulatory inspection preparation activities.
• Coordinate cross-functional inspection readiness initiatives across Quality, Manufacturing, Technical Operations, Engineering, Validation, Supply Chain, Regulatory Affairs, and other business functions.
• Develop and maintain comprehensive inspection readiness plans, timelines, deliverables, risk assessments, and tracking mechanisms.
• Facilitate inspection readiness governance meetings, steering committees, and executive updates.
• Lead and coordinate mock inspections, inspection simulations, document reviews, and readiness assessments.
• Partner with functional leaders to identify compliance gaps, assess risks, and implement effective remediation plans.
• Drive accountability across departments to ensure timely completion of readiness actions and commitments.
• Support preparation and management of inspection-related documentation, data requests, presentations, and response packages.
• Establish and maintain inspection war room processes, communication plans, and escalation pathways.
• Monitor readiness metrics and provide executive-level reporting on inspection preparedness, risks, and remediation progress.
• Partner with Quality leadership to strengthen sustainable quality systems, inspection management processes, and operational…