General Description: The Director, QMS Process Owner is responsible for overseeing and ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System processes. This role involves designing, implementing, and maintaining QMS processes in alignment with organizational goals, regulatory requirements, and industry standards. The Director, QMS Process Owner serves as the subject matter expert and point of accountability for their assigned QMS processes, driving a culture of quality and continuous improvement across the organization.
Essential Functions of the job:
Develop, implement, and maintain the Global Change Control process to ensure compliance with regulatory, customer, and organizational requirements.
Act as the primary point of contact for questions, issues, and audits related the Global Change Control process.
Define clear roles, responsibilities, and accountabilities for process execution.
Ensure process is compliant with applicable standards (e.g., ISO 9001, ISO 13485, ICH Q10) and regulations (e.g., FDA, EMA).
Maintain documentation, including procedures, templates, and work instructions, to support the QMS processes.
Monitor process performance using key performance indicators (KPIs) and other metrics.
Identify opportunities for process optimization and lead improvement initiatives.
Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for process-related issues.
Develop and deliver training for employees involved in the assigned processes.
Provide guidance and support to ensure proper execution of the process by stakeholders.
Establish and lead user communities for the assigned process to collaborate with cross-functional teams to integrate quality processes into business operations.
Ensure effective communication of process changes and updates to relevant stakeholders.
Represent the process area during audits, inspections, and management reviews
Perform other responsibilities as assigned.
Skills and Qualifications:
10+ years of related experience
5+ years of progressive leadership experience in quality management within a regulated industry (pharmaceutical, biotechnology, or medical devices).
Proven experience with QMS implementation and process ownership.
Deep understanding of quality management principles, regulatory frameworks, and industry standards (e.g., ISO 13485, ICH Q10).
Expertise in managing core QMS processes such as CAPA, change control, and deviation management.
Excellent communication, negotiation, and stakeholder management skills.
Strong analytical and problem-solving skills.
Proficient in data analysis, project management, and quality improvement methodologies (e.g., Lean, Six Sigma).
Ability to communicate complex information clearly and effectively across business functions
Travel: up to 20% internationally
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.