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Director, GMP Facility Launch & Operational Readiness

Job

ProPharma

Baltimore, MD (In Person)

Full-Time

Posted 4 days ago (Updated 17 hours ago) • Actively hiring

Expires 7/21/2026

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Job Description

Director, GMP Facility Launch & Operational Readiness at ProPharma Director, GMP Facility Launch & Operational Readiness at ProPharma in Baltimore, Maryland Posted in 1 day ago.
Type:
full-time
Job Description:
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 Customer validation support Mock runs and operational simulation Commercial go-live execution
Required Qualifications:
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 Validation strategy Batch record execution Operational readiness planning Regulatory inspection readiness Proven ability to lead highly cross-functional teams in deadline-driven environments.
Preferred Qualifications:
Prior experience with pharmaceutical manufacturing facility build out. Prior experience in sterilization technologies (NO?, EtO, VHP, steam, radiation, or related). Experience supporting pharmaceutical and medical device customers simultaneously. Experience in contract manufacturing, contract sterilization, or CDMO environments.
Familiarity with:
ISO 14937, ISO
13485, GMP and validation expectations PMP certification or equivalent program management experience preferred. •10 month contract position onsite in Hanover, MD