Director Quality Operations

JOB DESCRIPTIONTitle: Director, Quality OperationsDepartment: Quality ManagementReports To: Chief Quality OfficerFLSA Status: ExemptJob SummaryThe Director, Quality Operations is responsible for the management and continuous improvement of site Quality Systems, including customer and internal corrective/preventive actions, customer specification management, internal audits, and testing and inspection processes. This role also provides training, leadership, and professional development for team members.Essential FunctionsEnsure that facilities, equipment, materials, organization, processes, procedures, and products align with ISO 9001, ISO 13485, and applicable standards.Lead quality assurance processes across multiple regions and product lines to ensure products meet established quality standards.Provide oversight for high-risk product nonconformances, ensuring thorough investigations and effective corrective actions to prevent recurrence.Develop, implement, and maintain quality management systems and policies.Support internal and external audits, including certification and supplier audits.Lead the Quality team in identifying trends and implementing actions to mitigate adverse quality signals.Train and mentor personnel on quality control processes and best practices.Ensure appropriate staff development and training within areas of responsibility.Maintain documentation in accordance with industry standards.Stay current with evolving industry regulations and quality standards.Establish and track departmental goals aligned with organizational objectives.Identify opportunities for cost reduction and operational efficiency.Address employee concerns and partner with Human Resources as needed.Collaborate cross-functionally to ensure Quality Management System processes are effectively implemented and maintained.Champion continuous improvement initiatives within the QMS.Support development and management of Quality Agreements and supplier quality activities.Ensure compliance with company policies, procedures, and safety requirements (including PPE and ISO standards).Perform additional duties as assigned.EducationBachelor’s degree in Quality Management, Engineering, or related field required; Master’s preferred.Required Experience & Competencies5+ years of experience in quality management or a related field.Strong knowledge of quality assurance methodologies (e.g., Six Sigma, ISO 9001, ISO 13485).Minimum 3+ years of recent experience in pharmaceutical, biopharma, or medical device industries.Demonstrated expertise in quality assurance, regulatory compliance, and process improvement.Strong analytical and problem-solving skills.Proven leadership and team management capabilities.Proficiency in quality management systems and tools.Certification in Quality Management (e.g., CQE, CQM) preferred.Excellent written and verbal communication skills.Ability to manage multiple priorities and meet deadlines.Data-driven mindset with strong reporting and analysis capabilities.Proactive approach to continuous improvement and change management.