QA Document Control Lead (GMP/eQMS)

PCI Pharma Services; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a QA Manager – Document Control to lead our QA Document Control team across multiple facilities in a regulated GMP environment. You will manage controlled documents, procedures, and records while driving improvements in document control systems and mentoring staff.

The role includes overseeing eQMS administration, supporting client audits, and aligning document control with broader business objectives.

Qualifications

• Bachelor's degree in a related field with 5-8 years of experience in FDA-regulated environment.
• 5+ years Document Control experience; MasterControl preferred.
• Alternatively, a High School Diploma/Associate’s Degree with 10+ years of GMP experience.

Responsibilities

• Provide direction and oversight to QA Document Control team across multiple facilities, ensuring operational excellence.
• Mentor and manage team members, fostering professional development and a collaborative, high-performing culture.
• Promote clear, concise, and timely communication to senior management and cross-functional teams.
• Oversee issuance, revision, and archiving of GMP-controlled documents, including Batch Records, Testing Data Sheets, Equipment Log Books, and Quality System documents.
• Serve as the business process owner and administrator for the eQMS document module, ensuring continuous improvement and system optimization.
• Facilitate client approvals for Batch Records and manage periodic SOP reviews in collaboration with stakeholders.
• Conduct internal audits of the eQMS document module to ensure compliance with regulatory and organizational requirements.
• Support client audits and regulatory inspections by ensuring documentation readiness.
• Collaborate with cross-functional teams to address document control, aligning with broader business objectives.
• Identify and implement process improvements to enhance efficiency, compliance, and effectiveness within QA operations.
• Develop and maintain site-level metrics to monitor the performance of QA Document Control activities.
• Analyze data to identify trends, gaps, and opportunities for improvement, sharing actionable insights with leadership.
• Track and report compliance metrics, such as training completion rates, document approval timelines, and audit findings, to ensure consistent operational standards.
• Write and revise QA SOPs related to document control processes.
• Participate in investigations related to document control activities and recommend corrective actions.
• Perform other duties as assigned by senior management.

Skills

Leadership

Documentation

Regulatory compliance

Cross-functional teams

Education

Bachelor's degree in a related field

High School Diploma/Associate + GMP 10+ years

Tools

MasterControl

Job description

PCI Pharma Services is seeking a QA Manager – Document Control to lead our QA Document Control team across multiple facilities in a regulated GMP environment. You will manage controlled documents, procedures, and records while driving improvements in document control systems and mentoring staff.

The role includes overseeing eQMS administration, supporting client audits, and aligning document control with broader business objectives.