Position Title: Quality Assurance Manager/Senior Quality Assurance Manager
Department: Quality Assurance
This position is responsible for overseeing the internal and external quality assurance audit program to ensure regulatory compliance for a preclinical contract research organization. This role requires the ability to work closely and effectively with all levels of the organization as well as with external Sponsor auditors, consultants, and regulatory authorities. The Manager/ Senior Manager will also be responsible for oversight of the quality assurance and quality control activities to ensure regulatory compliance.
• Develop audit plans, conduct internal quality audits, prepare audit reports and communicate findings, including compliance risk.
• Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
• Conduct audits of outside vendors to qualify for GLP studies, prepare audit reports and communicate findings, including compliance risk.
• Recommends approval or disapproval of suppliers based on compliance assessment.
• Review and evaluate supplier’s audit response against current industry standards and guidelines to assure sufficient controls are in place by the vendor to meet company and quality requirements. Follow up on prior audit recommendations to ensure implementation and compliance.
• Assist in the maintenance of the annual internal and external audit schedules as requested by management.
• Lead for cause audits of external suppliers as requested by management.
• Assist in and/or lead the development of compliance and quality training as required.
• Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete the required audit tasks.
• Maintain audit files and databases to ensure all documentation is current and complete.
• Serve as host for client and regulatory audits/inspections, generate responses to all audit findings for review/approval by management.
• Maintain the NC/CAR system, which includes maintaining the non-compliance and corrective action requests log, generating and submitting reports, and tracking effectiveness of corrective actions.
• Generate and maintain documentation in support of the Quality Management System
• Day to day oversight of the QAU
• Review all SOPs to ensure compliance to applicable regulations
• Maintain SOPs for QAU functions
• Assumes additional duties and responsibilities as assigned.
• Thorough knowledge and understanding of GLP, OECD and other applicable regulations
• Must have GLP Quality Assurance experience
• Excellent language and communication skills required. Must be able to clearly communicate priorities and responsibilities on a daily basis. Must be able to convey complex ideas in easily understandable terms to both internal staff and outside auditors.
• Good listening skills essential. Must be able to elicit precise information from persons with varying professional expertise.
• Solid leadership skills essential. Must be able to lead both by example and through direct authority. Must be able to unite staff under common goals pertaining to quality.
• ISO 9001:2015 and ISO 10993 experience a plus
• Bachelors, Masters or Ph.D. degree in pharmaceutical sciences/pharmacology, toxicology or life sciences.
• Minimum B.S. with >10 years, M.S. with 5-10 years or PhD with 3-5 years GLP industry experience.