Quality Systems and Compliance Lead

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Equity participation

Life and AD&D insurance

401(k) matching

Discretionary paid time off

Opportunity to scale QMS

Job summary

Mount Kemble Search Group seeks an experienced Quality Systems & Compliance Lead to join a clinical-stage organization developing pharmaceutical and combination-product technologies. This hands-on role owns the QMS during regulatory activity and product development.

The successful candidate will manage audits, inspections, and compliance with FDA, ISO 13485, and 21 CFR Part 4 requirements while guiding cross-functional teams to scalable, practical processes in a fast-paced environment.

Qualifications

• Bachelor-level degree in a technical field related to quality or life sciences.
• 7+ years in Quality Assurance, Quality Systems, or regulatory/compliance within medtech, pharma, or combination products.
• Experience owning Quality System processes in FDA-regulated environments.
• Hands-on audit management and participation in regulatory inspections.
• Strong knowledge of FDA Quality System requirements and eQMS usage.

Responsibilities

• Own and manage QMS processes, including procedures, updates, and continuous improvement.
• Lead audits, internal and external, and manage findings and CAPA.
• Prepare for and participate in regulatory inspections and inspections readiness.
• Drive compliance with 21 CFR Part 4, ISO 13485, and applicable drug/device requirements.
• Develop quality metrics, dashboards, and management reporting for leadership.
• Collaborate across Development, Manufacturing, Regulatory, and Supply Chain.

Skills

Quality Assurance

Quality Systems

Regulatory Affairs

FDA Compliance

Audits

CAPA

Documentation

Leadership

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmaceutical Sciences

Tools

eQMS

Job description

We are seeking an experienced Quality Systems & Compliance Lead to join an innovative, clinical-stage organization developing pharmaceutical and combination-product technologies.

This is a highly visible, hands-on quality position responsible for helping build, maintain, and scale a robust Quality Management System (QMS) during a critical stage of product development, manufacturing readiness, regulatory activity, and commercial preparation.

Reporting to the Vice President of Quality, the Quality Systems & Compliance Lead will own key QMS processes, manage internal and external audit activities, support inspection readiness, and help ensure compliance with applicable FDA requirements, ISO 13485, and 21 CFR Part 4 combination-product requirements.

The ideal candidate is a self-directed Quality professional who understands regulated medical device, pharmaceutical, and/or combination-product environments and can translate regulatory requirements into practical, scalable processes. This is an excellent opportunity for someone who enjoys building systems, improving processes, and working across multiple functions in a fast-paced, growing organization.

Key Responsibilities

Quality Management System

• Own and manage assigned QMS processes, including procedure maintenance, implementation, monitoring, metrics, and continuous improvement.
• Serve as process owner or deputy owner for areas such as:
• Document control
• Training
• Change control
• CAPA
• Nonconformances
• Complaints
• Audits
• Management Review
• Quality metrics
• Ensure QMS procedures, records, and practices remain aligned with FDA requirements, ISO 13485, internal policies, and business needs.
• Support electronic Quality Management Systems (eQMS), quality workflows, dashboards, and scalable processes supporting clinical development and manufacturing readiness.
• Help ensure the QMS is positioned to support future commercialization and organizational growth.

Audits, Inspections & Inspection Readiness

• Manage the internal audit program, including audit planning, execution, reporting, finding management, corrective action follow-up, and effectiveness verification.
• Coordinate and support external audits of suppliers, contract manufacturers, CDMOs, sterilization providers, testing laboratories, consultants, and other service providers.
• Serve as a Quality representative during customer, partner, certification body, and regulatory audits or inspections.
• Maintain ongoing inspection readiness by ensuring QMS records, audit evidence, quality metrics, responses, commitments, and remediation actions are accurate, organized, current, and tracked through closure.

Combination Product & Regulatory Compliance

• Support the development and continuous improvement of the organization's combination-product quality framework.
• Drive awareness and execution of 21 CFR Part 4 requirements across applicable drug, device, development, manufacturing, supplier, and Quality activities.
• Support the integration of:
• Design controls
• Purchasing controls
• CAPA
• Production controls
• Documentation practices
• Identify process and compliance gaps and help develop practical solutions.
• Provide QMS documentation and compliance evidence to support regulatory submissions, partner due diligence, and customer or sponsor requests.

Quality Governance & Continuous Improvement

• Develop and maintain quality metrics, dashboards, trends, and status reports for Quality leadership.
• Support Management Review, including preparation and analysis of:
• Audit outcomes
• CAPA trends
• Supplier Quality performance
• Compliance risks
• Proactively identify compliance risks, process gaps, documentation issues, and opportunities to improve QMS effectiveness and efficiency.
• Lead or support cross-functional Quality initiatives designed to strengthen accountability, operational discipline, inspection readiness, and patient safety.
• Partner closely with Development, Manufacturing, Regulatory, Supply Chain, and external partners.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmaceutical Sciences, or a related technical discipline.
• 7+ years of experience in Quality Assurance, Quality Systems, Compliance, or a related function within the medical device, pharmaceutical, biotechnology, or combination-product industry.
• Demonstrated experience owning or managing Quality System processes in an FDA-regulated environment.
• Hands-on experience managing internal audits and supporting external audits.
• Experience preparing for or participating in regulatory inspections.
• Strong working knowledge of FDA Quality System requirements.
• Experience with electronic Quality Management Systems (eQMS) and quality-record workflows.
• Experience with technical writing, document review, root cause analysis, CAPA, quality metrics, and management reporting.
• Strong organizational, communication, and cross-functional leadership skills.
• Ability to influence stakeholders without direct authority and drive actions through completion.
• Highly self-directed, detail-oriented, accountable, and comfortable operating in a fast-paced environment with changing priorities.

Preferred Qualifications

• Experience within a startup, early-stage, clinical-stage, or rapidly scaling organization.
• Experience supporting combination products and 21 CFR Part 4 compliance.
• Experience working with external suppliers, contract manufacturers, CDMOs, laboratories, and other regulated service providers.
• Demonstrated ability to develop practical and scalable Quality Systems while maintaining regulatory compliance and inspection readiness.

Working Conditions

• This is a 100% onsite position in Portsmouth, New Hampshire.
• Occasional domestic and international travel may be required for supplier, manufacturing-partner, and audit activities.
• Some off-hours availability may be necessary during audits, regulatory inspections, submissions, or critical development and manufacturing activities.
• The position requires responsiveness when urgent Quality, compliance, audit, inspection, or development-program needs arise.

What We Offer

• Direct-hire, full-time opportunity
• Competitive compensation
• Equity participation
• Basic life and AD&D insurance
• 401(k) matching
• Discretionary paid time off
• Opportunity to help build and scale a sophisticated combination-product Quality Management System
• High-visibility role with direct interaction across Quality, Regulatory, Manufacturing, Development, and executive leadership