About this opportunity
Jobtailor lists this Director, Quality Operations opportunity in bedford, New Hampshire. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
Requirements
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 cleanrooms 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
Core Competencies
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.
Highest-signal resume keywords
Quality Management Systems (QMS)
Pharmaceutical Manufacturing
Regulatory Compliance (CFR 210, 211, 820)
Aseptic Processing
Industrial Management Skills
ATS Optimization Keywords
Hard Skills
Aseptic Operations
Microbiology
Analytical Chemistry
Validation
Process Controls
Continuous Improvement
Budget Management
Staffing Management
GEMBA Observations
Training and Competency Development
Soft Skills
Leadership
Coaching
Collaboration
Communication
Decision-Making
Certifications & Qualifications
Bachelor Degree or Equivalent Experience
Industry Keywords
GMP Manufacturing
Contract Manufacturing
CGXP
ICH Q8
ICH Q9
ICH Q10
EU/Eudralex
Batch Disposition
Employee Safety
Quality Mindset
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Worksite address
bedford, NH, 03110, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.