Director of Quality Assurance

Description

McCrone Associates, Inc. is a small, privately owned analytical laboratory primarily specializing in microanalysis services for the pharmaceutical, life sciences and other industries. As an ISO/IEC 17025 accredited laboratory, we are committed to scientific rigor, data integrity, regulatory compliance, and exceptional client service. We are seeking a Director of Quality Assurance to lead our quality program, oversee regulatory compliance, and support our continued growth and technical excellence.

The Director of Quality Assurance is responsible for developing and implementing quality assurance strategies, policies, and procedures. This position ensures that the laboratory's Quality Management System (QMS), remains in compliance with ISO/IEC 17025 standards and applicable regulatory expectations (cGxP, USP, etc.). This role works closely with laboratory leadership, the QA Manager, internal auditors, scientists, and clients to uphold the highest standards of data quality, documentation, and operational efficiency.

Key Responsibilities

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• Develop and implement the strategic quality assurance vision and roadmap aligned with
  the company's goals and objectives.
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• Develop, maintain, and continually improve quality policies, procedures, and documentation.
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• Oversee internal and external audits, proficiency testing, and corrective/preventive action (CAPA) programs.
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• Oversee change control, document control, training records, and controlled document lifecycle management including administration of the document management system.
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• Ensure instrument and software system qualifications are ISO, GMP and GAMP compliant.
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• Ensure laboratory practices comply with applicable GMP/GLP and regulatory requirements, including data integrity standards.
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• Conduct root cause investigation and lead cross-functional problem-solving initiatives.
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• Train and mentor laboratory staff regarding quality procedures, regulatory compliance, and best practices.
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• Interface with clients regarding quality-related inquiries, audit responses, and technical agreement requests.
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• Monitor industry trends and regulatory updates to proactively guide quality system enhancements.
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• Also responsible for general office staff that support client services and facilities.
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Requirements

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• Bachelor's degree in Chemistry, Biology, Quality Management, Pharmaceutical Sciences, or related field; advanced degree preferred.
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• Minimum 10 years experience in a regulated laboratory environment, with GMP/GLP quality assurance experience and knowledge of GAMP 5 validation practices.
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• In-depth knowledge of ISO/IEC 17025 requirements and laboratory accreditation processes.
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• Demonstrated experience in quality systems management, audit leadership, CAPA programs, controlled documentation management system administration, and LIMS validation, implementation and change control.
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• Strong communication skills, leadership abilities, and a collaborative working style.
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• Experience with microanalysis or small-scale analytical testing environments is a plus.
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