Aseptic Sterility Assurance Director – On-the-Floor Leader

PCI Pharma Services; Bedford (NH); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

PCI Pharma Services in Bedford, NH seeks a Director of Sterility Assurance to lead the site’s aseptic manufacturing quality program, ensuring readiness for inspections and compliance with global regulations. The role requires 12+ years in a similar organization with at least five in management within aseptic production, and a strong background in regulatory guidance (CFR 210/211, 820, ICH Q8/9/10).

The director will drive CAPAs, EMPQ/APS processes, and QMS data management across functions.

Qualifications

• Requires a minimum of a bachelor degree, with preference for those in life sciences, engineering or other science disciplines. An advanced degree is desirable.
• Approximately 12+ years' experience in a similar organization with at least five of those years in a management role, with the vast majority of this experience gained in an aseptic or sterile production environment.
• Contract Manufacturing experience is a plus
• A formal background in Industrial Microbiology and Contamination Control is desired
• Requires an advanced knowledge of global regulatory guidance including CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1) related to Aseptic Manufacturing and testing.
• Hands-on experience with QMS data management software (eQMS), process mapping tools, risk assessments, data analysis, and software for presentation of all of these is required.

Responsabilités

• Oversees the Aseptic Core Monitoring (ACM) program and ensures SMEs witness aseptic processes.
• Leads contamination control and aseptic practices with direct reports and QA teams.
• Manages EMPQ and APS processes and aligns local/customer requirements.
• Supports audits, deviations and CAPAs with risk assessments and data tools.
• Performs data trending and reporting for contamination control and environmental data, supports QMRs and Tier processes.
• Owns cleaning and disinfection programs and coordinates with EHS to reduce environmental impact.
• Ensures Sterility Assurance is on the shop floor and visible to operators and inspectors.

Connaissances

Leadership

Regulatory knowledge

Cross-functional leadership

Data analysis

Risk assessment

Aseptic/ GMP

Formation

Bachelor degree in life sciences/engineering

Advanced degree desirable

Outils

eQMS

Process mapping tools

Description du poste

PCI Pharma Services in Bedford, NH seeks a Director of Sterility Assurance to lead the site’s aseptic manufacturing quality program, ensuring readiness for inspections and compliance with global regulations. The role requires 12+ years in a similar organization with at least five in management within aseptic production, and a strong background in regulatory guidance (CFR 210/211, 820, ICH Q8/9/10).

The director will drive CAPAs, EMPQ/APS processes, and QMS data management across functions.