Director, GMP Facility Launch & Operational Readiness

Consultant: Director, GMP Facility Launch & Operational Readiness

Summary

Duties / Expectations of Role

• 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

• Serve as the executive program leader for launch of a new contract sterilization operation.
• Own the integrated operational readiness strategy and execution plan through commercial go-live.
• Develop and maintain the master program schedule aligned to a May 1, 2027 operational launch.
• Lead cross-functional governance across:
  • Quality & Regulatory
  • Validation & Process Engineering
  • Operations
  • Technical/Lab Support
  • Facilities & EHS
  • Commercial & Customer Onboarding

• Establish executive reporting, KPIs, risk dashboards, and escalation mechanisms.
• Drive accountability for milestone execution and resolve cross-functional conflicts rapidly.

Facility & Technical Readiness

• Ensure facility readiness for regulated contract sterilization operations, including:

• • Material and personnel flow
  • Product segregation
  • Environmental readiness
  • Safety systems and gas handling controls
• Lead coordination of equipment installation, commissioning, and qualification activities.
• Oversee completion of:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Ensure cycle control systems, calibration, maintenance, and operational controls are fully implemented before launch

Quality & Compliance Leadership

• Partner with Quality leadership to ensure an audit-ready operational framework aligned with:
  • ISO 14937
  • ISO 13485
  • GMP expectations for pharmaceutical and medical device customers
• Oversee implementation and readiness of:
  • Core QMS procedures
  • Batch record systems
  • Deviation/CAPA programs
  • Change control
  • Document control
  • Training systems
• Ensure internal audit readiness prior to go-live.

• Direct development of operational systems required for launch, including:
  • Material intake and chain-of-custody
  • Scheduling and capacity planning
  • Operator training and qualification
  • Batch execution workflows
  • Release pathways
• Lead mock batch execution and full end-to-end operational simulations.
• Require and oversee multiple “stress test” scenarios, including intentional deviations and failure modes, to validate system robustness before launch.
• Lead controlled commercial ramp during the first 60–90 days post-launch.

• Ensure readiness for regulated customer onboarding including:
  • Statements of Work (SOWs)
  • Quality agreements
  • Validation support pathways
  • Customer audits
  • Technical transfer requirements
• Support onboarding of initial strategic customers and first validation programs.

• Own enterprise risk identification and mitigation for:
  • Schedule delays
  • Validation bottlenecks
  • Documentation gaps
  • Quality readiness failures
  • Staffing readiness
  • Customer onboarding risks
• Drive critical early decisions including:
  • Release model strategy (parametric vs BI-based)
  • Internal vs outsourced laboratory support
  • Capacity and staffing model
  • Product/customer prioritization strategy

Mandatory Requirements

• 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.

• 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.

• Go–live achieved without critical readiness gaps
• Facility fully audit-ready prior to first commercial batch
• IQ/OQ/PQ milestones completed on time
• Batch record system successfully demonstrated through mock execution
• Successful onboarding of first commercial customers
• First commercial batch accepted, processed, released, and invoiced successfully
• Stable operational launch during first 60–90 days

• Highly execution-oriented and decisive
• Technically credible with GMP/validation leaders
• Comfortable leading in ambiguity and start-up conditions
• Able to influence without direct authority across functions
• Calm under pressure and deadline-driven
• Strong at converting complex programs into executable plans
• Willing to be highly hands-on during critical launch periods

• 10+ month contract with conversion to permanent.
• Start ASAP
• Full time (40 hours/week)
• 100% Hanover, MD
• No Travel
• Benefits included (Medical, Dental, Vision, 401k)