Key Responsibilities and Required Skills for Quality Compliance Manager

🎯 Role Definition

Are you a seasoned quality professional passionate about upholding the highest standards of safety, efficacy, and compliance? This role requires a dynamic and strategic Quality Compliance Manager to join our growing team. In this pivotal role, you will be the guardian of our Quality Management System (QMS), ensuring that every process and product not only meets but exceeds the stringent requirements of global regulatory bodies like the FDA and ISO. You will act as a key leader, driving a culture of quality-first thinking across all departments and playing a critical part in our mission to deliver safe and effective products to the market.

This position requires a hands-on leader who can manage both the strategic oversight of our compliance framework and the tactical execution of quality initiatives. If you thrive in a collaborative environment and possess a deep understanding of regulatory landscapes, we invite you to apply.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Quality Assurance Engineer
Regulatory Affairs Specialist / Manager
CAPA Manager or Lead Investigator
Senior Supplier Quality Engineer

Advancement To:

Director of Quality Assurance
Senior Director of Quality & Regulatory Affairs
Head of Global Compliance
Vice President (VP) of Quality

Lateral Moves:

Supplier Quality Engineering Manager
Risk Management Manager
Operations Manager
Validation Manager

Core Responsibilities

Primary Functions

Develop, implement, and continuously improve the company's Quality Management System (QMS) to ensure full compliance with FDA 21 CFR 820, ISO 13485, cGMP, and other applicable international quality and regulatory standards.
Lead the internal audit program by planning, executing, and reporting on audits to assess compliance with established procedures and regulations, and drive the closure of any findings.
Act as the primary host and point of contact for external audits and inspections from regulatory agencies (e.g., FDA, Notified Bodies) and key partners, ensuring company-wide readiness and managing all logistical and follow-up activities.
Manage the CAPA (Corrective and Preventive Action) system, overseeing the investigation of non-conformances, conducting thorough root cause analysis, and tracking the implementation and verification of effective solutions.
Oversee the document control and records management system, ensuring that all SOPs, work instructions, quality manuals, and other critical documents are properly created, reviewed, approved, distributed, and maintained.
Chair the Management Review meetings, preparing comprehensive data-driven reports on the performance of the QMS and presenting key metrics, trends, and improvement opportunities to executive leadership.
Manage the supplier quality program, including the qualification, auditing, and performance monitoring of critical suppliers and contract manufacturers to ensure they meet our quality requirements.
Lead and mentor a team of quality professionals, providing guidance, training, and development opportunities to foster a high-performance, compliance-focused culture.
Review and approve validation protocols and reports (IQ/OQ/PQ) for equipment, processes, and software to ensure they are robust and compliant.
Oversee the complaint handling process, ensuring all customer feedback and product complaints are documented, investigated, and resolved in a timely and compliant manner.
Direct the non-conforming material process, ensuring proper identification, segregation, investigation, and disposition of materials that do not meet specifications.
Collaborate with R&D, Manufacturing, and Engineering teams during new product development to provide quality and compliance input and ensure design controls are properly implemented.
Monitor the regulatory landscape for changes in standards and regulations, assessing the impact on the QMS and implementing necessary updates to maintain compliance.
Manage the quality training program, ensuring all employees are adequately trained on the QMS, relevant SOPs, and regulatory requirements specific to their roles.
Generate, analyze, and report on key quality performance indicators (KPIs) to identify trends, signal potential issues, and drive data-based decision-making for continuous improvement.

Secondary Functions

Partner with Regulatory Affairs to support the preparation and submission of regulatory filings by providing necessary quality data and documentation.
Lead or participate in cross-functional risk management activities in accordance with ISO 14971, including the development and maintenance of risk management files.
Support change control processes by reviewing proposed changes to products, processes, or the QMS to ensure they are properly justified, documented, and approved.
Provide quality oversight for post-market surveillance activities, including the analysis of data and preparation of periodic safety reports.
Serve as a Subject Matter Expert (SME) on quality and compliance topics, providing guidance and interpretation of regulations to all functional areas of the organization.

Required Skills & Competencies

Hard Skills (Technical)

Expert Knowledge of Regulations: Deep, practical understanding of FDA regulations (e.g., 21 CFR Part 820, 210/211) and international standards such as ISO 13485 and ISO 14971.
QMS Architecture & Management: Proven ability to design, implement, and maintain a compliant and efficient Quality Management System from the ground up.
Auditing Expertise: Certified lead auditor (e.g., ASQ CQA, ISO 13485 Lead Auditor) with extensive experience leading internal, supplier, and regulatory audits.
CAPA & Root Cause Analysis: Mastery of investigative techniques and structured problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify true root causes.
Risk Management: Proficiency in applying risk management principles (ISO 14971) to product lifecycle and quality processes.
eQMS Software Proficiency: Hands-on experience with electronic Quality Management System (eQMS) platforms for modules like Document Control, CAPA, Training, and Audits.
Validation Principles: Strong understanding of process, equipment, and software validation (IQ, OQ, PQ) requirements in a regulated environment.

Soft Skills

Leadership & Influence: Ability to lead, mentor, and motivate a team, as well as influence cross-functional stakeholders without direct authority to drive quality initiatives.
Communication: Exceptional verbal and written communication skills, with the ability to articulate complex regulatory concepts clearly to diverse audiences, from technicians to senior executives.
Problem-Solving: Proactive and solutions-oriented mindset with strong analytical and critical thinking skills to effectively resolve complex compliance challenges.
Attention to Detail: Meticulous and thorough approach to documentation, review, and analysis to ensure accuracy and compliance.
Project Management: Strong organizational and project management skills to handle multiple complex projects simultaneously and meet deadlines.
Negotiation & Diplomacy: Adept at navigating interactions with regulatory inspectors and auditors with professionalism, confidence, and diplomacy.
Adaptability: Ability to thrive in a fast-paced, dynamic environment and adapt to evolving regulations and business needs.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree from an accredited university or college.

Preferred Education:

Master's Degree (MS or MBA)
Relevant professional certifications, such as ASQ Certified Quality Manager (CQM/OE), Certified Quality Auditor (CQA), or RAPS Regulatory Affairs Certification (RAC).

Relevant Fields of Study:

Biomedical Engineering, Chemical Engineering, or another engineering discipline
Life Sciences (e.g., Biology, Chemistry, Microbiology)
Health Sciences or a related technical field

Experience Requirements

Typical Experience Range:

A minimum of 8-12 years of progressive experience in Quality Assurance, Regulatory, or Compliance roles within a regulated industry.
At least 3-5 years of experience in a management or leadership position, with direct supervisory responsibilities.

Preferred:

Direct experience in the medical device, pharmaceutical, or biotechnology industry is strongly preferred.
Demonstrated success in hosting FDA inspections and/or ISO audits is highly desirable.
Experience with combination products or sterile manufacturing environments is a significant plus.