Director, GMP Facility Launch & Operational Readiness

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

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 (NO₂, 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

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***