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quality systems compliance manager

title: Key Responsibilities and Required Skills for Quality Systems & Compliance Manager
salary: $95,000 - $150,000
categories: [Quality Management, Regulatory Compliance, Medical Device, Pharmaceutical, Manufacturing]
description: A comprehensive overview of the key responsibilities, required technical skills and professional background for the role of a Quality Systems & Compliance Manager.
Hiring: Quality Systems & Compliance Manager — experienced quality leader to own QMS, regulatory readiness, audits (internal & supplier), CAPA, risk management, and change control. Ideal candidate has hands-on experience with ISO 9001 / ISO 13485, FDA 21 CFR Part 820 or relevant GMP frameworks, supplier quality oversight, and a continuous improvement mindset. Strong written and verbal skills for policy development, training, and executive reporting required.

🎯 Role Definition

The Quality Systems & Compliance Manager is responsible for designing, maintaining, and continuously improving the Quality Management System (QMS) and compliance programs to ensure product quality, regulatory readiness, and operational excellence. This role leads internal and supplier audits, manages CAPA and change control processes, aligns quality objectives with business strategy, and serves as the primary liaison for regulatory inspections and cross-functional compliance initiatives. Ideal candidates will demonstrate measurable improvements in compliance metrics, audit outcomes, and supplier performance through data-driven quality practices.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Engineer (Senior)
  • Compliance Specialist / Regulatory Affairs Specialist
  • Supplier Quality Engineer

Advancement To:

  • Director of Quality Systems & Compliance
  • Head of Quality / VP of Quality
  • Senior Regulatory Affairs or Quality Operations Leader

Lateral Moves:

  • Supplier Quality Manager
  • Quality Assurance Manager (Operational QA)
  • Validation Manager

Core Responsibilities

Primary Functions

  • Lead the design, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) including document control, record retention, training matrices, and electronic QMS tools to ensure compliance with ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), and relevant GMP requirements.
  • Develop, own, and execute the internal audit program (schedule, scoping, auditor selection, findings follow-up), perform root cause analysis, and drive corrective and preventive actions (CAPA) through to verification of effectiveness, ensuring closure within agreed timelines.
  • Act as the primary point of contact for external regulatory inspections and notified body audits; prepare regulatory response packages, host inspection activities, manage nonconformances, and lead remediation programs to resolution.
  • Lead supplier qualification and oversight programs, including supplier risk assessment, audits, performance metrics, supplier corrective actions, and integration of supplier quality requirements into procurement and supplier agreements.
  • Manage change control processes spanning product design changes, process changes, equipment changes, and software or system updates; assess regulatory impact, coordinate approvals, and update controlled documentation accordingly.
  • Establish and monitor quality KPIs and dashboards (e.g., CAPA backlogs, audit findings, nonconforming material incidents, supplier PPM, OCR) and deliver regular executive-level reporting and data-driven recommendations for continuous improvement.
  • Oversee complaint handling and field actions: triage complaints, perform trending and impact assessments, coordinate investigations, determine reportability, and support recalls or voluntary corrective actions as required.
  • Lead cross-functional risk management activities (FMEA, risk assessments, mitigation plans) to identify, prioritize, and reduce product and process risks across development and manufacturing.
  • Develop and deliver quality and compliance training programs for manufacturing, engineering, and commercial personnel to ensure consistent understanding and adherence to procedures, regulations, and quality culture.
  • Manage technical file/technical documentation and support regulatory submissions and registrations (e.g., EU MDR, 510(k), CE Technical Files), ensuring conformity with applicable standards and timely submission of required documentation.
  • Drive supplier and internal audit programs for GMP, ISO, and product-specific standards; plan corrective action plans, define timelines, and validate effectiveness of solutions implemented.
  • Maintain and control quality system documentation, including SOPs, work instructions, forms, validation protocols, and master control documents, ensuring timely review, approval, and change history tracking.
  • Lead investigations for product nonconformances and deviations using structured problem-solving methodologies (8D, DMAIC), including containment actions, root cause identification, remediation planning, and validation of corrective actions.
  • Coordinate equipment qualification and process validation activities in partnership with engineering and production teams; review validation protocols, execute fit-for-purpose testing, and ensure documentation meets regulatory audit expectations.
  • Collaborate with Product Development and Manufacturing to embed quality-by-design principles, conduct design reviews for compliance implications, and ensure transfer-to-manufacturing activities meet quality requirements.
  • Drive continuous improvement initiatives using lean, Six Sigma, and statistical process control (SPC) tools to reduce defect rates, scrap, and rework, and to enhance yield and first-pass quality.
  • Oversee supplier change notifications and supplier CAPA process, ensuring changes are evaluated for impact and properly validated or requalified as necessary.
  • Maintain vigilance on evolving regulatory and standards landscape; translate regulatory changes into actionable impacts for the business and update QMS policies and procedures accordingly.
  • Manage budget and resource planning for quality systems initiatives, audits, and training programs, ensuring priorities are aligned with company compliance and commercial objectives.
  • Serve as the interface with cross-functional teams — R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Legal — to ensure timely alignment on compliance strategies, labeling, and reporting obligations.
  • Lead the preparation, consolidation, and submission of management review materials; present quality performance, risks, improvements, and strategic recommendations to senior leadership.
  • Implement and maintain electronic quality systems (eQMS) and tools for document control, CAPA, complaints, and audit management; partner with IT for system validation, user access controls, and continuous enhancement.

Secondary Functions

  • Support supplier development projects by providing quality requirements and acceptance criteria during supplier onboarding and new supplier qualification.
  • Contribute to product lifecycle governance by supporting post-market surveillance, vigilance reporting, and trending analysis for product improvements.
  • Participate in cross-functional product risk reviews and launch readiness assessments to ensure product releases meet quality and regulatory expectations.
  • Provide ad-hoc quality consultation for process troubleshooting, continuous improvement workshops, and design transfer activities.
  • Assist in the preparation of quality content for customer-facing documents such as quality manuals, Q&As, and compliance statements.
  • Mentor and coach junior quality staff; support hiring, professional development, and performance reviews in the quality organization.

Required Skills & Competencies

Hard Skills (Technical)

  • Quality Management Systems (QMS) implementation and administration (ISO 9001, ISO 13485).
  • Regulatory compliance knowledge: FDA 21 CFR Part 820 / QSR, EU MDR, and applicable GMP/ICH guidelines.
  • CAPA management, root cause analysis (8D, Ishikawa, 5 Whys), and verification of effectiveness.
  • Internal and supplier audit planning and execution, audit reporting, and remediation follow-up.
  • Change control, document control, and configuration management best practices.
  • Supplier quality management: qualification, auditing, performance metrics, and CAPA.
  • Risk management techniques: FMEA, risk assessments, and mitigation planning.
  • Process validation and equipment qualification (IQ/OQ/PQ).
  • Complaint handling, vigilance reporting, and product recall management.
  • Quality metrics, KPI development, and data-driven reporting (Excel, BI tools).
  • Statistical tools (SPC, Minitab, basic DOE) for process monitoring and improvement.
  • eQMS and quality software experience (e.g., MasterControl, TrackWise, Greenlight Guru, Veeva).
  • Technical writing for SOPs, validation protocols, and regulatory submissions.
  • Knowledge of industry-specific standards where applicable (e.g., IEC 62304, ISO 14971 for medical devices; HACCP/BRC for food).

Soft Skills

  • Strong leadership and people management with experience leading cross-functional improvement initiatives.
  • Excellent written and verbal communication for regulatory submissions, executive reporting, and training.
  • Analytical, data-driven decision-making and the ability to translate metrics into action plans.
  • Problem-solving mindset with attention to detail and commitment to quality culture.
  • Project management skills, ability to prioritize and manage multiple compliance projects concurrently.
  • Influencing and stakeholder management to drive change across functions and suppliers.
  • Resilience under inspection pressure and ability to manage urgent corrective actions effectively.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality Assurance, or related technical discipline.

Preferred Education:

  • Master’s degree in Quality Management, Regulatory Affairs, Engineering, or related field.
  • Professional certification such as ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ CQE, or Certified ISO Lead Auditor.

Relevant Fields of Study:

  • Mechanical, Chemical, Biomedical or Industrial Engineering
  • Quality Assurance / Regulatory Affairs
  • Life Sciences, Biology, Chemistry
  • Manufacturing Engineering / Operations Management

Experience Requirements

Typical Experience Range: 5–10+ years of progressive quality assurance and compliance experience, including direct QMS ownership and audit management.
Preferred: Experience in regulated industries (medical device, pharmaceutical, biotechnology, or food safety), with demonstrated success managing regulatory inspections, supplier quality programs, and enterprise eQMS deployments. Experience leading cross-functional teams and implementing CAPA and risk management programs is highly desirable.

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