Global Compliance & Quality Director

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 140,000 - 190,000; Full time

Job summary

PCI Pharma Services in New Hampshire is seeking a Director of Compliance to lead the QA Compliance team and ensure alignment with global regulatory requirements. You will orchestrate internal audits, external inspections, CAPA programs, and risk management across aseptic manufacturing operations.

The role requires deep knowledge of CFR and ICH guidelines, strong leadership, and the ability to host regulatory inspectors on site.

Qualifications

• Bachelor’s degree in life sciences or related field is required.
• About 10+ years in a similar organization with at least five years in a management role.
• Experience in aseptic or sterile production environments preferred.
• Deep knowledge of CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex Annex 1.
• Hands-on with QMS data management software (eQMS) and risk assessment tools.
• Ability to communicate compliance status and prepare for regulatory inspections.

Responsibilities

• Leads QA Compliance team activities including internal audits and regulatory inspections.
• Oversees risk management program and CAPA investigations.
• Manages audit observations, deviations, and product quality events.
• Hosts regulatory inspectors and ensures readiness site-wide.
• Collaborates with manufacturing and other stakeholders to improve QMS.

Skills

QA Compliance

Audits

CAPA investigations

Risk management

QMS

Regulatory inspections

Regulatory guidance

Education

Bachelor's degree in Life Sciences

Advanced degree desirable

Tools

eQMS

Job description

PCI Pharma Services in New Hampshire is seeking a Director of Compliance to lead the QA Compliance team and ensure alignment with global regulatory requirements. You will orchestrate internal audits, external inspections, CAPA programs, and risk management across aseptic manufacturing operations.

The role requires deep knowledge of CFR and ICH guidelines, strong leadership, and the ability to host regulatory inspectors on site.