Director, GMP Facility Launch & Operational Readiness (Pharmaceutical)

TL;DR

Director, GMP Facility Launch & Operational Readiness (Pharmaceutical): Leading the enterprise-level execution of critical site launch programs with an accent on facility completion, GMP readiness, and equipment qualification. Focus on driving operational readiness, implementing quality systems, and ensuring successful commercial go-live execution in highly regulated environments.

Location: Onsite in Hanover, MD, USA

Company

hirify.global is a professional services firm providing end-to-end consulting solutions to biotech, medical device, and pharmaceutical organizations through an advise-build-operate model.

What you will do

• Lead enterprise-level execution of GMP site launch programs.
• Oversee facility completion, GMP readiness, and equipment installation and qualification (IQ/OQ/PQ).
• Implement quality systems and finalize batch record release systems.
• Manage operational readiness, staffing, and operational simulation/mock runs.
• Provide customer validation support and coordinate commercial go-live execution.

Requirements

• Must be based in or able to work onsite in Hanover, MD.
• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related field.
• 15+ years of leadership experience in pharmaceutical, biologics, medical device, or sterilization manufacturing.
• Demonstrated success leading GMP manufacturing facility start-ups and major operational launches.
• Strong working knowledge of IQ/OQ/PQ execution and validation strategies.

Nice to have

• Prior experience with sterilization technologies (NO₂, EtO, VHP, steam, radiation).
• Experience in CDMO or contract manufacturing environments.
• Familiarity with ISO 14937, ISO 13485, and GMP validation expectations.
• PMP certification or equivalent program management experience.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Work environment that encourages innovative and entrepreneurial spirits.
• Personal review of all applications by the recruitment team without the use of AI screening tools.
• Supportive atmosphere where employees are empowered to succeed.