Director of Quality & Regulatory Compliance

PCI Pharma Services; Bedford (NH); On-site; USD 150,000 - 210,000; Full time

Job summary

PCI Pharma Services seeks a seasoned Director of Compliance to lead QA compliance activities, audits, and regulatory inspections. The role drives risk management within the QMS and collaborates with Manufacturing and other stakeholders to ensure FDA guideline compliance.

With 10+ years in a similar setting and a strong background in aseptic production, you will guide CAPA investigations, regulatory communications, and contract quality activities across the site.

Qualifications

• Requires a minimum of a bachelor’s degree with preference for life sciences, chemistry, engineering or related disciplines.
• Approximately 10+ years in a similar organization with at least five years in a management role, with aseptic/sterile production experience.
• Contract Manufacturing experience is a plus.
• Industry experience outside Quality as well as core Quality experience is a plus.
• Advanced knowledge of global regulatory guidance (CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex incl. Annex 1) and WHO/ANVISA as needed.

Responsibilities

• Oversees QA Compliance team activities including internal audits, external inspections, vendor and customer audits, and APQR.
• Develops technical acumen and decision-making in direct reports.
• Manages risk management program and integrates it into QMS with stakeholders.
• Leads audit, deviation, and CAPA investigations.
• Ensures compliance status is communicated and improvements are implemented across processes.

Skills

Regulatory knowledge

Leadership

Audit management

QMS data management

Communication

Strategic planning

Education

Bachelor's degree in life sciences or related field

Advanced degree desirable

Tools

eQMS

Process mapping

Data analysis

Regulatory reporting

Job description

PCI Pharma Services seeks a seasoned Director of Compliance to lead QA compliance activities, audits, and regulatory inspections. The role drives risk management within the QMS and collaborates with Manufacturing and other stakeholders to ensure FDA guideline compliance.

With 10+ years in a similar setting and a strong background in aseptic production, you will guide CAPA investigations, regulatory communications, and contract quality activities across the site.