Quality Assurance Leader

The Quality Assurance Leader is responsible for developing implementing and sustaining an effective Quality Management System (QMS) across all company locations. This role leads the deployment of QMS software ensures continued ISO 9001 compliance strengthens quality and documentation systems and supports safe consistent and compliant chemical manufacturing operations. The position serves as the primary quality authority for internal and external audits customer quality inquiries root cause analysis and company-wide quality training while partnering closely with Operations EHS Engineering and Regulatory teams.

Role Responsibilities:

Quality Management System (QMS) & Documentation Control

• Design implement and maintain a robust QMS aligned with ISO 9001 and chemical manufacturing best practices.
• Lead implementation and own ongoing administration of QMS software (document control training records CAPA change management).
• Ensure controlled documentation for SOPs batch records specifications work instructions and quality records.
• Standardize quality systems and procedures across all manufacturing sites.

ISO 9001 Compliance & Regulatory Alignment

• Maintain ISO 9001 certification across all applicable sites.
• Serve as management representative for ISO 9001 and quality system compliance.
• Monitor standard changes and integrate requirements into the QMS.
• Ensure quality systems align with applicable chemical manufacturing regulations and industry expectations (e.g. OSHA EPA TSCA REACH customer-specific requirements).

Audit Management

• Lead and support external audits including ISO certification audits customer audits and third-party audits.
• Plan and conduct internal quality system audits across all sites.
• Prepare sites for audits including readiness assessments and corrective action planning.
• Ensure timely and effective closure of audit findings and nonconformances.

Root Cause Analysis & Corrective / Preventive Action (CAPA)

• Implement a standardized root cause analysis and CAPA methodology across all sites.
• Ensure effective investigation of quality events process deviations off-spec material and customer complaints.
• Verify effectiveness of corrective and preventive actions.
• Promote a risk-based and data-driven approach to quality improvement.

Training & Quality Culture

• Develop and deliver company-wide training on QMS requirements ISO 9001 document control deviation management and RCA methodologies.
• Ensure personnel are trained and qualified for their roles in accordance with quality and safety requirements.
• Build a strong culture of quality ownership compliance and continuous improvement across operations.
• Coach site-level quality and operations personnel.

Continuous Improvement & Cross-Functional Leadership

• Initiates and implements quality assurance improvement activities as appropriate to raise the performance of the companys quality system.
• Establishes and implements system for review and improvement of QMS by senior leadership to foster sound quality focused decisions.
• Interacts with customers to identify opportunities to improve overall service quality and establish feedback with internal stakeholders.
• Assist Sourcing in quality assessments of supplier performance and establish criteria and rating system for critical suppliers.
• Other duties as directed by the management.

Skills Qualifications Experience Special Physical Requirements:

Required

• Bachelors degree in chemistry Engineering Quality or related field
• 7 years of progressive Quality Assurance or Quality Systems experience in chemical or process manufacturing.
• Demonstrated experience implementing and maintaining a QMS in a multi-site manufacturing environment.
• Prior experience with QMS software implementation and administration.

• In depth knowledge of ISO9001 compliance related to specialty chemicals

• Experience leading internal external and customer audits.
• Proven expertise in root cause analysis and CAPA methodologies.

• Effective communication and people skills to collaborate across departments.
• Ability to prioritize tasks manage multiple projects simultaneously and meet deadlines.

• Strong training communication and leadership skills.

Preferred

• Experience in manufacturing industrial or regulated environments.
• Experience leading organizational change and system rollouts across multiple locations.
• Familiarity with additional standards (e.g. ISO 14001 IATF 16949 AS9100) is a plus.
• Knowledge of additional standards or frameworks (e.g. ISO 14001 Responsible Care GMP)
• Familiarity with process safety concepts management of change (MOC) and risk assessments.
• ISO 9001 Lead Auditor certification.

Key Competencies

• Systems thinking in regulated manufacturing environments.
• Strong documentation and change management discipline
• Cross-functional leadership and influence
• Data-driven problem solving
• Audit readiness and regulatory awareness
• Firsthand leadership with a continuous improvement focus

Disclaimer:

The list of requirements duties and responsibilities is not exhaustive but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when circumstances of the job change.