Quality Operations, Facilities & Validation

Responsibilities

• Support and execute cGMP quality assurance activities directly related to facilities, equipment, utilities, and automation assets for clinical trial material supply.
• Provide Quality oversight for the capital project lifecycle across design phases, qualification, operational readiness, and start-up for cross-modality facilities.
• Oversee key cGMP processes, including calibration, validation, change management, quality risk management, and root-cause quality investigations.
• Partner with rapidly expanding internal teams to establish strong quality oversight, collaborative communication, and effective cross-organizational alignment.
• Apply current industry best practices and benchmarks to the design, implementation, and maintenance of pilot/clinical-scale facilities and equipment.
• Sustain existing facility operations and manufacturing readiness alongside new capital project developments.

Requirements

• Minimum Required: Bachelor’s degree in science, engineering, or a related technical discipline.
• Preferred: Advanced degree (Master's or Ph.D.) in science, engineering, or a related field.
• Minimum Required: At least 8 years of experience within the Pharmaceutical or Biotechnology industry.
• Proven experience in Quality, Operations, or related functions at a pilot and/or commercial scale.
• Strong working knowledge and practical application of Current Good Manufacturing Practice (cGMP).
• Demonstrated working knowledge of capital project execution and facility operations.
• Strong interpersonal, negotiation, conflict resolution, and written/verbal communication skills.
• Preferred: Direct experience in R&D, clinical trial supply material manufacturing, or clinical supply areas.
• Founded knowledge across validation disciplines (equipment, utilities, automation, unit operations, process development, or technology transfer).
• Foundational knowledge across validation disciplines (equipment, utilities, automation, unit operations, process development, or technology transfer).
• Background in managing cross-functional technical teams and leading complex problem-solving initiatives.
• Proficiency in capital project lifecycles from concept through design and start-up.

Qualifications

• Education: Minimum Required: Bachelor’s degree in science, engineering, or a related technical discipline.
• Preferred: Advanced degree (Master's or Ph.D.) in science, engineering, or a related field.

Skills

• Current Good Manufacturing Practice (cGMP)
• Capital project execution
• Facility operations
• Interpersonal, negotiation, conflict resolution, and communication skills
• Validation disciplines (equipment, utilities, automation, unit operations, process development, or technology transfer)
• Managing cross-functional technical teams
• Leading complex problem-solving initiatives
• Proficiency in capital project lifecycles

Benefits

• Not specified

Pay

• Not specified

Schedule

• Not specified