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Type:

full-time

Job Description:

Quality Systems & Compliance Lead Location:

Portsmouth, NH Schedule:

100%

Onsite Employment Type:

Direct Hire, Full-Time Position Overview 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 Risk management Purchasing controls CAPA Production controls Complaint handling 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 Complaint trends Compliance risks Continuous improvement activities 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 supporting product development, manufacturing readiness, regulatory submissions, partner due diligence, or commercial scale-up. 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 Comprehensive health, dental, and vision benefits Basic life and AD&D insurance 401(k) matching Discretionary paid time off Collaborative, mission-driven work environment 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","type","jobPosting","source","LC","accountId","106869338","organizationName","Mount Kemble Search Group","applicationUrl","https://www.disabledperson.com/jobs/75418591-quality-systems-and-compliance-lead","New Castle, NH","isRemote","location",{"_323":324,"_325":326},"createdAt","2026-09-25T06:39:50.345775490Z","updatedAt","2026-09-25T13:31:49.281Z","publishedAt","2026-09-22T00:00:00Z","expiresAt","2026-10-26T00:00Z","status","active","isExpired","isDiscoverable",true,"isSearchable","isSpotlight","isDraft","careerSkills",[170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219],"requiredEducation","4_college","benefitCategories",[167,168,169],"isEmailRequired","isPhoneRequired","formattedDescription","

Quality Systems and Compliance Lead at Mount Kemble Search Group Quality Systems and Compliance Lead at Mount Kemble Search Group in New Castle, New Hampshire Posted in about 7 hours ago.

Type:

full-time

Quality Systems & Compliance Lead Location:

Portsmouth, NH Schedule:

100%

Onsite Employment Type:

Support the integration of:

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Find & Apply For Quality Control Systems Manager Jobs in New Castle, New Hampshire

Quality Systems and Compliance Lead