Director, Quality Operations

PCI Pharma Services

Bedford (NH)

Sur place

USD 120 000 - 180 000

Plein temps

14 jours+

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Résumé du poste

PCI is seeking a functional quality leader to drive quality operations across multiple business units in Bedford, NH. You will balance worker safety, environmental compliance, finance, production, supply, and customer needs while guiding the Quality Operations Asset Leadership Team on the shop floor.

You will oversee QMS and regulatory systems, coach frontline teams, ensure training and competency, manage budgets, and serve as the customer-facing Quality organization.

Qualifications

5+ years’ experience in pharmaceutical / GMP manufacturing.
Aseptic processing experience highly preferred.
Experience managing a team across multiple shifts.
Knowledge of CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex.
Minimum Bachelor degree or equivalent experience.

Responsabilités

Serve as the functional quality leader for multiple business units.
Balance worker safety, quality, environmental compliance, and customer needs.
Lead the Quality Operations Asset Leadership Team and coach shop floor teams.
Oversee QMS and other systems to maximize Right-First-Time manufacturing.
Provide feedback to QMS owners to improve performance.
Maintain visibility into batch disposition requirements and final disposition steps.
Deliver predictable quality outcomes through continuous improvement and controls.
Schedule, assign, monitor, and trend GEMBAs and process observations.
Manage Quality professionals across shifts and drive compliance.
Foster collaboration and share best practices among frontline personnel.
Empower the team to make sound shop floor decisions with review.
Serve as the customer-facing Quality organization and primary contact for communications.
Act as a visible leader and example of PCI’s Industrial Quality Mindset.
Develop staff, strengthen process knowledge, and ensure succession planning.
Develop and meet budgets.

Connaissances

Quality Management Systems (QMS)

Pharmaceutical Manufacturing

Regulatory Compliance CFR 210 211 820

Aseptic Processing

Industrial Management Skills

GEMBA Observations

Budget Management

Staffing Management

Training and Competency Development

Quality Mindset

Formation

Bachelor Degree or Equivalent Experience

Outils

GEMBA Observations

Validation

Description du poste

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.

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