GMP Facility Launch & Operational Readiness

ELIQUENT Life Sciences; Hanover (MD); On-site; USD 180,000 - 280,000; Full time

Job summary

ELIQUENT Life Sciences in the United States is launching a new contract GMP facility. The Director, GMP Facility Launch & Operational Readiness will own the end-to-end readiness for facility, equipment, quality systems, staffing, and release processes to enable the first commercial batch.

This role requires executive presence, deep regulatory manufacturing knowledge, and a proven track record in starting up GMP operations with rigorous compliance and schedule discipline.

Qualifications

• PMP Certification is mandatory.
• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences or related field.
• 15+ years of leadership experience in regulated manufacturing.

Responsibilities

• Lead the cross-functional site launch program from readiness to go-live.
• Own governance, integrated master schedule, and risk mitigation.
• Coordinate Quality, Validation, Engineering, Operations, and Commercial teams.
• Ensure audit-ready GMP facility startup and successful first commercial batch.

Skills

Leadership

GMP

Project management

Regulatory readiness

Education

PMP Certification

Bachelor's degree in Engineering or Life Sciences

Advanced degree preferred

Job description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We are building a fully operational, audit-ready contract sterilization capability supporting pharmaceutical and medical device customers. The site will provide feasibility, validation, and commercial sterilization services in a regulated environment supporting highly demanding customer and regulatory expectations. We are seeking an experienced Director-level leader to own the cross-functional execution of facility readiness, qualification, operational launch, and customer onboarding for a new contract sterilization operation. This role is accountable for ensuring the organization is fully prepared to accept, process, release, and invoice the first commercial batch.

Position Summary

The Director, GMP Facility Launch & Operational Readiness will lead enterprise-level execution of a critical site launch program spanning:

• Facility completion and GMP readiness
• Equipment installation and qualification (IQ/OQ/PQ)
• Quality system implementation
• Operational readiness and staffing
• Batch record finalization and release systems
• Mock runs and operational simulation
• Commercial go-live execution This individual will serve as the single accountable leader for operational readiness, driving alignment across Quality, Validation, Engineering, Operations, EHS, Technical/Laboratory, and Commercial teams. The Director will establish program governance, own the integrated master schedule, remove organizational barriers, and proactively mitigate risks to ensure a successful, audit-ready launch. This is a highly visible role requiring executive presence, strong technical credibility in regulated manufacturing, and demonstrated experience leading GMP facility start-ups.

Education & Qualification Requirements

• PMP (Project Management Professional) Certification is mandatory.
• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Manufacturing, or related discipline; advanced degree preferred.
• 15+ years of leadership experience in pharmaceutical, biologics, medical device, sterilization, or highly regulated manufacturing environments.

Demonstrated success leading:

• GMP manufacturing facility start-ups
• Major facility build-outs or operational launches
• Cross-functional readiness programs
• Equipment commissioning and qualification initiatives

Strong working knowledge of:

• IQ/OQ/PQ execution
• GMP manufacturing systems
• Batch record execution
• Operational readiness planning
• Regulatory inspection readiness

• Proven ability to lead highly cross-functional teams in deadline-driven environments.