Key Responsibilities and Required Skills for Quality Compliance Specialist

🎯 Role Definition

A Quality Compliance Specialist ensures that products, processes and systems meet internal quality standards and external regulatory requirements. This role owns aspects of the Quality Management System (QMS), leads compliance activities, conducts audits and investigations, drives corrective and preventive actions (CAPA), and partners cross-functionally to reduce risk and enable continuous improvement across manufacturing, supply chain and product development.

Key search terms: Quality Compliance Specialist, Quality Assurance, Regulatory Compliance, QMS, CAPA, ISO 9001, GMP/GxP, internal audit, supplier quality, risk management, FDA compliance.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Technician / Quality Inspector
Compliance Analyst or Regulatory Affairs Associate
Manufacturing or Operations Associate with quality exposure

Advancement To:

Senior Quality Compliance Specialist / Senior Quality Assurance Specialist
Quality Manager / Compliance Manager
Regulatory Affairs Manager
Director of Quality or Head of Compliance

Lateral Moves:

Supplier Quality Engineer / Supplier Quality Manager
Continuous Improvement / Lean Six Sigma roles
Operations or Manufacturing Management

Core Responsibilities

Primary Functions

Develop, implement and maintain elements of the Quality Management System (QMS) including SOPs, work instructions and controlled documents to ensure compliance with ISO standards and company policy.
Lead and execute internal quality audits and compliance assessments across manufacturing sites, laboratories and office locations, producing audit reports with clear findings, root causes and prioritized remediation plans.
Plan, coordinate and support external regulatory inspections (e.g., FDA, EMA) and customer audits by preparing evidence packages, facilitating interviews and ensuring timely closure of inspection observations.
Investigate product quality issues and nonconformances using root cause analysis tools (5 Whys, Ishikawa, FMEA) and author robust CAPA plans with measurable effectiveness checks.
Monitor and report on key quality metrics (e.g., OOS, OOT, deviation rates, CAPA aging, audit scores) and deliver actionable insights to leadership to drive continual improvement.
Manage change control processes for product, process and documentation changes, assessing regulatory impact and ensuring appropriate approvals and training prior to implementation.
Oversee supplier qualification, onboarding and periodic assessments, including supplier audits, scoring, corrective actions and monitoring of delivered quality metrics.
Review and approve manufacturing batch records, release documentation and certificates of analysis to ensure conformance with specifications and regulatory requirements.
Maintain and administer training programs for quality systems, compliance processes and technical standards; ensure training records are complete and effectively retained.
Execute complaint handling and adverse event investigations for product or service related complaints, ensuring timely reporting to regulatory authorities where required.
Support design transfer and new product introduction activities by providing quality requirements, risk assessments and design verification/validation oversight.
Develop and maintain regulatory dossiers, quality agreements and technical files required for product registration and market access in regulated regions.
Implement and manage environmental, health and safety (EHS) related quality controls where they intersect with product compliance and manufacturing practices.
Facilitate cross-functional CAPA review boards and change control committees to ensure alignment of corrective actions with business objectives and timelines.
Lead statistical process control (SPC) activities and process capability studies to assess stability and implement process improvements that reduce variability and defects.
Maintain document control systems and electronic quality systems (eQMS), ensuring document lifecycle, version control and audit trails meet regulatory expectations.
Partner with engineering, manufacturing and supply chain teams to resolve root causes of recurring defects and implement sustainable corrective actions that minimize production disruptions.
Prepare, present and communicate quality and compliance status, trends and risk assessments to senior management and external stakeholders.
Ensure data integrity and compliance with GxP data principles across laboratory information management systems (LIMS), ERP and quality databases.
Coordinate product recalls and field actions when necessary, managing communication plans, containment activities and regulatory reporting.
Drive continuous improvement initiatives using Lean, Six Sigma or other methodologies to reduce waste, improve yield and enhance product quality.
Maintain awareness of evolving regulatory requirements, industry guidance and standards, translating regulatory changes into operational updates and training.
Support supplier nonconformance resolution, including issuing supplier corrective actions, verification activities and maintaining supplier CAPA closure evidence.
Develop test plans and protocols for investigation and validation activities and ensure appropriate documentation of methods, results and conclusions.
Act as the primary quality liaison on cross-functional projects such as process scale-up, facility transfers and contract manufacturing transitions.

Secondary Functions

Support ad-hoc data requests and exploratory analysis of quality metrics to identify trends and improvement opportunities.
Contribute to the organization’s quality strategy, roadmap and continuous improvement program by providing assessment data and recommended priorities.
Collaborate with business units to translate compliance and quality requirements into actionable operational plans and system requirements.
Participate in project governance, sprint planning and agile ceremonies for initiatives to deploy or improve electronic quality systems (eQMS) and analytics.
Mentor junior quality staff and support professional development through training, coaching and performance feedback.
Assist procurement and supplier management teams with quality requirements during vendor selection and contract negotiations.
Maintain records and evidence to support external certifications (ISO, ISO 13485, ISO 9001) and corporate quality objectives.

Required Skills & Competencies

Hard Skills (Technical)

Quality Management Systems (QMS) administration and document control experience (e.g., eQMS platforms such as MasterControl, TrackWise, Veeva).
Regulatory knowledge including ISO 9001/13485, FDA QSR, 21 CFR Part 11, GMP/GxP principles and global regulatory frameworks.
Auditing skills: planning, executing and reporting internal, supplier and regulatory audits with proven ability to manage audit closure.
CAPA management, root cause analysis and verification of effectiveness using formal methodologies.
Risk management methods such as FMEA, HACCP or similar tools to evaluate and mitigate product and process risks.
Statistical analysis and process capability (SPC, Six Sigma tools, Minitab or equivalent) to analyze trends and support improvement.
Strong documentation and change control expertise for batch release, deviations, engineering changes and regulatory filings.
Supplier quality management including qualification, performance monitoring, nonconformance handling and quality agreements.
Data integrity and quality of electronic records management across LIMS, ERP, MES and eQMS tools.
Experience with complaint handling, field actions, recalls and regulatory reporting requirements.
Project management skills to lead cross-functional quality improvement and compliance initiatives.
Familiarity with quality-related software (Excel advanced, SQL basics for querying QA data, BI tools like Power BI or Tableau).
Validation and verification experience for equipment, processes and computerized systems (IQ/OQ/PQ).
Knowledge of product lifecycle quality activities including design transfer, D&V and post-market surveillance.

Soft Skills

Excellent oral and written communication skills for clear audit reports, regulatory correspondence and stakeholder updates.
Strong analytical thinking and attention to detail to detect quality trends and identify root causes.
Influencing and interpersonal skills to collaborate effectively with engineering, manufacturing, suppliers and leadership.
Problem-solving and critical thinking with ability to prioritize actions under tight timelines.
Project orientation and organizational skills to manage multiple quality initiatives concurrently.
Adaptability and resilience in dynamic, regulated environments with changing priorities.
Coaching and mentoring skills to develop junior team members and promote a quality culture.
Integrity and ethical judgment with commitment to product safety and regulatory compliance.
Customer-focused mindset when handling complaints, supplier issues or cross-functional quality requests.
Time management and decision-making under uncertainty.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Quality Assurance, Engineering, Chemistry, Biology, Life Sciences, Manufacturing, or related technical field.

Preferred Education:

Bachelor’s or Master’s degree with specialization in Quality, Regulatory Affairs, Industrial Engineering, or MBA with demonstrated quality experience.
Professional certifications such as CQE, CQA, Six Sigma (Green/Black Belt), ISO Lead Auditor, or RAC are advantageous.

Relevant Fields of Study:

Quality Assurance / Quality Engineering
Industrial or Manufacturing Engineering
Biology, Chemistry or Life Sciences
Regulatory Affairs / Compliance

Experience Requirements

Typical Experience Range: 3–7 years of progressive quality, compliance or regulatory experience in manufacturing, pharmaceutical, medical device, biotech or regulated consumer products.

Preferred:

5+ years in quality compliance roles with direct ownership of QMS elements, audits, CAPA and supplier quality.
Demonstrated experience supporting regulatory inspections and managing complex CAPA and recall activities.
Hands-on experience with eQMS systems, LIMS, ERP integration and statistical process control tools.