Director, Quality Operations

• Serve as the functional quality leader for multiple business units
• Understand and balance worker safety, quality, environmental compliance, finance, production, supply, and customer needs
• Lead the Quality Operations Asset Leadership Team, visibly solve employee-area issues, and coach shop floor teams
• Control and monitor execution of PCI’s QMS and other systems to maximize employee focus and Right-First-Time manufacturing
• Provide feedback to QMS system owners to improve performance
• Maintain systems providing clear visibility into batch disposition requirements and final disposition steps
• Deliver predictable quality outcomes through continuous improvement, process controls, operational monitoring, and consistent communication and decision-making
• Schedule, assign, monitor, and trend shop floor GEMBAs and process observations
• Manage Quality professionals across multiple shifts and drive compliance and consistency
• Foster collaboration and sharing of experiences and best practices among front-line quality personnel
• Empower the team to make sound shop floor decisions while maintaining review and sharing systems
• Serve as the customer-facing Quality organization and primary contact for customer communications
• Act as the local visible leader and example of PCI’s Industrial Quality Mindset
• Develop staff, strengthen process knowledge, and ensure succession planning
• Develop and meet budgets

• Approximately 5+ years’ experience in pharmaceutical / GMP manufacturing
• Aseptic processing experience highly preferred
• Past experience as a supervisor or manager of employees beneficial
• Contract Manufacturing experience is a plus
• Experience working in a regulated industry highly preferred
• Knowledge of global regulatory guidance, including CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex including Annex 1 prioritized
• Experienced industrial management skills required
• Ability to meet budget and manage weekly and daily staffing
• Ability to ensure training and competency are available
• Working knowledge of production, aseptic operations, microbiology, analytical chemistry, and validation required
• Minimum of a bachelor degree or equivalent relevant experience or certifications
• Preference for life sciences, chemistry, engineering, or other science disciplines
• Ability to sit, reach, use computers and office equipment, and stand for extended periods up to four hours
• Ability to gown into clean rooms or aseptic spaces regularly
• Ability to lift up to 20 pounds
• Close and distant-range vision with hand and eye coordination
• Ability to communicate with others

Demonstrates expertise in Quality Management Systems (QMS) within pharmaceutical manufacturing, emphasizing compliance with global regulatory standards and continuous improvement processes. Proven ability to lead teams, manage budgets, and ensure training and competency in a regulated environment.

• Quality Management Systems (QMS)
• Pharmaceutical Manufacturing
• Regulatory Compliance (CFR 210, 211, 820)
• Aseptic Processing
• Industrial Management Skills

• Aseptic Operations
• Microbiology
• Analytical Chemistry
• Validation
• Process Controls
• Continuous Improvement
• Budget Management
• Staffing Management
• GEMBA Observations
• Training and Competency Development

• Leadership
• Coaching
• Collaboration
• Communication
• Decision-Making

• Bachelor Degree or Equivalent Experience

• GMP Manufacturing
• Contract Manufacturing
• CGXP
• ICH Q8
• ICH Q9
• ICH Q10
• EU/Eudralex
• Batch Disposition
• Employee Safety
• Quality Mindset