Director, Quality Operations

pciservices; Bedford (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

PCI is seeking a QO Director to lead Quality Operations across multiple shifts, ensuring GMP compliance and robust quality systems. You will guide asset leadership, coach shop-floor teams, and drive Right-First-Time manufacturing with a focus on patient safety.

The role includes maintaining batch disposition processes, managing budgets, and serving as the primary customer contact for quality issues. Experience in aseptic processing and regulated pharma is required.

Qualifications

• Approximately 5+ years' experience in pharmaceutical / GMP manufacturing.
• Aseptic processing experience is highly preferred
• Past experience as a supervisor or manager of employees is beneficial
• Contract Manufacturing experience is a plus
• Experience working in a regulated industry with CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex

Responsibilities

• Lead Quality Operations across multiple shifts with focus on compliance.
• Coach shop floor teams and align decisions with quality objectives.
• Monitor and improve QMS and systems to maximize productivity and patient safety.
• Manage budgets and ensure batch disposition processes are traced and compliant.
• Serve as primary customer contact for quality-related escalations.

Skills

GMP

Aseptic processing

Supervision

Contract manufacturing

Regulatory knowledge

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

As the functional quality leader for multiple business units, the QO Director understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. With the Asset Leadership Team, the QO Asset Lead visible and solves issues relevant to our employees in the area, and coaches the shop floor teams to work collaboratively and with solutions in mind.

Controls and monitors the execution of PCI's QMS and other systems to ensure they are functioning effectively and in such a way as to maximize employee focus and enable Right-First-Time manufacturing. Provides consistent feedback to QMS system owners on how to improve performance.

Maintains systems that provide a clear line-of-sight to batch disposition requirements, tracking discrete steps that lead to final disposition including, but not limited to those owned in the Asset (batch record review, deviation management) and those provided by partners (QC data, EM results).

Deliver predictable quality outcomes through continuous improvement, process controls, monitoring of operational activity, and consistent communication and decision-making. Administers (schedules, assigns, monitors and trends) the shop floor GEMBAs and process observations to empower area Ops leaders to make informed choices on priority and criticality of initiatives.

Manages a team of Quality professionals across multiple shifts, driving for compliance and consistency in routine operation and in response to upset conditions (events or deviations). Fosters community across the front-line quality personnel on site and in the network to share experiences and best practices to continuously trend toward more aligned decisions.

Empowers their team to make the right call on the shop floor, but also always provides systems for review and sharing to ensure decisions made are the best possible. Leads the team as a coach as much as possible, while never risking patient safety.

Quality Operations has the full understanding of production operations, decisions, and issues and as such, are the customer-facing Quality organization. The QO Asset Lead is the primary contact for customer communications, supported in escalations by the SDQO when necessary.

The incumbent is the local visible leader, setting the example of PCI's Industrial Quality Mindset. They do not only focus on the most current 'emergency' only. They invest time developing staff and ensuring a strong process knowledge and succession planning in the Asset area.

Ensures budgets are developed accurately and are met.

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly required to sit, and to reach to use computers and other office equipment
• constantly stand for extended periods of time, up to four (4) hours/time.
• required to gown into cleanrooms or into aseptic spaces on a regular basis
• frequently required to lift up to 20 pounds
• constantly required to view objects at close and distant ranges with hand and eye coordination
• frequently required to communicate with others

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Approximately 5+ years' experience in pharmaceutical / GMP manufacturing.
• Aseptic processing experience is highly preferred
• Past experience as a supervisor or manager of employees is beneficial
• Contract Manufacturing experience is a plus
• Experience working in a regulated industry is highly preferred, with knowledge of global regulatory guidance in including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (includin