Quality Assurance Director

Certified Group

$150K — $180K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Master's degree in Microbiology, Chemistry, Food Science, or related scientific discipline required.
  • Minimum of 10 years in a regulated GMP and/or Quality Assurance environment.
  • 5 years in a Quality leadership role overseeing teams and Quality systems.
  • Hands-on experience with multi-site Quality Management Systems (QMS).
  • At least 2 years experience in a commercial testing laboratory or similar regulated environment.
  • Strong knowledge of ISO/IEC 17025 and GMP regulations required.
  • Certification in quality standards (e.g. ASQ, SQA) preferred.

Responsibilities

  • Lead compliance with regulatory, GMP, and accreditation standards across business units.
  • Maintain the Quality Management System (QMS) in alignment with ISO and GMP requirements.
  • Provide strategic leadership in Quality operations to enhance customer satisfaction.
  • Oversee internal audit programs ensuring adherence to QMS standards.
  • Develop and manage Quality KPIs, analyze data, and implement corrective actions.
  • Administer and enhance the QMS, updating it per regulatory changes and internal needs.
  • Facilitate Management Review processes and communicate QMS performance to leadership.

Benefits

  • Robust career development and training opportunities.
  • Collaboration with cross-functional teams in a dynamic environment.
  • Direct impact on product quality and compliance at an organizational level.
  • Opportunity to lead and shape the Quality culture within the organization in a critical sector.
Full Job Description


Job Summary

The Corporate Quality Director is responsible for the leadership, oversight, and continuous improvement of the Quality Assurance function and Quality Management System (QMS) across Certified Group's Personal Care & Cosmetics division.

This role ensures the effective application, validation, and oversight of approved test methods and analytical techniques used in product testing and evaluation. The Director is accountable for ensuring compliance with applicable regulatory, GMP, and accreditation requirements, including ISO/IEC 17025, USDA requirements, Good Manufacturing Practice (GMP) regulations, 21 CFR Parts 210, 211, and 21 CFR Part 11, as well as customer-specific requirements.

This leader is responsible for driving a strong culture of quality, compliance, and continuous improvement aligned with Certified Group's purpose and values:

Purpose: So the world can trust in what it consumes
Mission: Partner with customers to deliver innovative scientific solutions and expertise
Values: Customer focus, safety and quality, delivery excellence, integrity, and teamwork
Responsibilities
  • Lead and maintain regulatory, GMP, and accreditation compliance across assigned business units, including oversight of all registrations, certifications, and regulatory obligations.
  • Ensure the Quality Management System (QMS) is maintained in full compliance with ISO standards, GMP requirements, and applicable regulatory frameworks.
  • Provide strategic and operational leadership to the Quality organization, ensuring effective execution of daily operations, continuous improvement, and strong customer satisfaction outcomes.
  • Oversee the internal audit program, ensuring audits are executed according to the approved schedule and QMS requirements.
  • Develop, implement, and manage Quality KPIs and metrics; analyze trends and drive corrective and preventive action plans based on data-driven insights.
  • Own the ongoing administration, governance, and improvement of the QMS, ensuring timely updates in response to regulatory changes, industry expectations, and internal business needs.
  • Lead Management Review processes and ensure effective communication of Quality system performance to senior leadership.
  • Serve as the primary Quality leader for external regulatory inspections, surveillance audits, and customer audits, partnering closely with Laboratory and Technical leadership teams.
  • Ensure audit readiness across all facilities and drive timely, effective closure of audit findings, including major and critical nonconformances.
  • Provide hands-on training and coaching across all elements of the QMS as needed to strengthen organizational capability and consistency.
  • Identify, lead, and execute initiatives to reduce errors, improve compliance, and enhance overall quality performance across the network.
  • Interpret complex technical and quality data and provide clear summaries and executive-level reporting.
  • Escalate significant quality risks, compliance issues, and systemic concerns to Business and Executive Leadership in a timely and structured manner.
Education & Experience

  • Master's degree in Microbiology, Chemistry, Food Science, or related scientific discipline required.
  • Minimum of 10 years of progressive experience in a regulated GMP and/or Quality Assurance environment.
  • Minimum of 5 years in a Quality leadership role with responsibility for managing teams and/or multi-site Quality systems.
  • Demonstrated experience leading enterprise or multi-site Quality Management Systems (QMS) in a regulated environment.
  • Experience leading and developing Quality teams, including direct and indirect reports, with responsibility for performance management and talent development.
  • At least 2 years of experience in a commercial testing laboratory or equivalent regulated environment.
  • Strong working knowledge of ISO/IEC 17025, GMP regulations, and applicable regulatory frameworks.
  • Experience influencing cross-functional and senior leadership stakeholders in a complex organization.
  • Experience with Lean Six Sigma or other continuous improvement methodologies preferred.
  • Laboratory and/or technical auditing experience preferred.
  • ASQ, SQA, or equivalent quality certifications (e.g., auditing credentials) strongly preferred.
  • Hands-on microbiological and/or chemical testing experience preferred.
  • Strong written and verbal communication skills required.

#LI-JM

The compensation details provided below reflect the expected pay range for this role, based on the selected compensation structure and applicable guidelines. Actual pay within this range may vary depending on factors such as experience, skills, qualifications, and geographic location. Additional components of total rewards-such as bonuses, benefits, or incentives-may also apply where applicable.

Salary Range for Pay Transparency

$150,000-$180,000 USD

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