Associate Director – Quality

Associate Director – Quality

Requirements

• Three or Four year Bachelor’s degree in Chemistry, a related field, or a foreign equivalent plus 6 years of progressively responsible post-baccalaureate experience in job offered or any chemical engineering/quality assurance related job titles.
• 6 years of experience with the following: (1) Pharmaceutical or CDMO industries including experience with cGMP principles, practices, and standards; (2) GXP statutory requirements and regulations; (3) Review and approve investigations, Change Controls, CAPAs and Risk Assessments; (4) establishing overall quality systems and procedures for US FDA compliant manufacturing facilities; (5) being responsible for lot release operations and commercial batch dispositions; (6) Preparing, interfacing, hosting and leading customer and regulatory audits; (7) acting as a quality liaison for multiple product partnerships with Contract manufacturers, customers, and distributors; (8) Authoring, Reviewing and establishing Quality Agreements with customers, contract facilities & suppliers; (9) Approving/Rejecting finished product for distribution.

Responsibilities

• Establish and maintain risk-based and fit-for-purpose QMS. Develop, implement, and communicate quality policies and procedures across cGMP at Axolabs Petaluma.
• Assess cGMP regulatory compliance risks and implement mitigation strategies.
• Maintain and develop supplier quality management systems ensuring that suppliers meet regulatory requirements and LGC Axolabs standards.
• Establish new ways to improve the LGC QMS, data integrity initiatives and facilitate operational and quality improvement projects.
• Present and lead regular quality reviews to leadership e.g. oversight of deviation event classifications, batch record review timeliness and other GMP quality management system performance metrics. Report and escalate compliance issues to leadership.
• Collaborate with stakeholders to identify, define and implement opportunities for improved eQMS platforms.
• Manage and mentor a team of QA and QC professionals to work within a global vertically integrated organization.
• Work with subject matter experts to ensure that QC investigations follow regulatory standards.
• Maintain timely closure of deviations, CAPAs, and change controls.
• Provide directives and manage the personnel to assure that QC training is in a state of compliance with all LGC Axolabs and current industry and regulatory standards.
• Implement appropriate systems to enable the efficient operation of the QC laboratory.
• Record and identify metrics to monitor current manufacturing processes and identify and implement process improvements.
• Represent the company at stakeholder and regulatory audits through clear and concise description of QC procedures, laboratory practices and documentation.
• Represent QC/QA in cross-functional and stakeholder meetings.
• Implement applicable regulatory guidelines and directives e.g. ICH, USP, 21CFR.

Preferred Qualifications

• 20% domestic travel required for regulatory conferences, quality audits for raw materials and labs.