Position Summary

The Quality Director will lead the development, implementation, and continuous improvement of the company's quality management systems and processes, ensuring that all products meet the highest standards of quality, integrity, and functionality. This role will collaborate with cross-functional teams, driving quality initiatives, strategic production evaluations, and corrective measures to prevent and resolve quality challenges. The Quality Director will ensure alignment with industry standards and customer expectations, fostering a culture of excellence and operational efficiency across all manufacturing sites. The candidate should have excellent communication skills to effectively collaborate with cross-functional teams and stakeholders.

Essential Functions

• Develop a solid quality organization with focus on 'zero defects' and improving customer experience
• Lead a team of quality professionals across multiple sites to achieve corporate quality objectives and ensure ongoing compliance and sustainability of the Quality Management System
• Manage complex interdepartmental and interdisciplinary relationships to assure collaboration and effective/efficient operations within Quality - Patient Safety.
• Remain current with new regulations and standards including cGMP (21 CFR 110/111, 210/211), DEA, and ISO requirements; provide technical and quality leadership and support to all applicable sites and help prepare the organization for FDA and other compliance audits
• Actively maintain knowledge of current best practices of Personal Health Care Product portfolio
• Ensure key metrics and drivers of success are established, monitored and used to proactively identify areas for improvement to avoid quality shortfalls
• Develop a robust training program to keep quality top of mind, educate new associates, maintain proficiency, share lessons/best practices and rapidly shore up deficiencies
• Encourage a culture of continuous improvement; research the quality data generated at customer sites to identify opportunities for improvement, assess any adverse trends, and develop strategic action plans to ensure ongoing compliance with applicable regulatory and customer requirements.
• Handle quality improvement initiatives and utilize risk management principles to proactively identify areas of risk
• Continuously monitor the effectiveness of the Quality Management System and provide regular updates to the corporate leadership team on performance against quality metrics and goals
• Create an environment that encourages diverse opinions, recognize differences and incorporate them into process and services.
• Exhibits awareness of personal attitudes and beliefs, recognizing its effect on response to others.
• Creates a culture and systems for recognizing and rewarding staff
• Validation team to start

Qualifications

• 15+ years of experience working in the Healthcare/Pharmaceutical industry with at least 5 years in a leadership role managing quality systems.
• Prior experience in managing Quality Management Systems registered to International Quality Standards (e.g. ISO 9001:2015, ISO 13485:2016, etc.)
• Demonstrated knowledge of applicable regulations such as FDA 21 CFR 110/111, 21 CFR 210/211, DEA, Health Canada and ISO 13485:2016 requirements
• Proven experience with Lean, Six Sigma, and other continuous improvement methodologies.
• Solid research skills, problem-solving ability and presentation skills
• Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
• Proven ability to manage people, build relationships and understand what motivates others
• Excellent verbal and written communication skills with ability to tailor approach toward the perspective of others
• Demonstrated ability to interact effectively with individuals at all levels and working closely with others over geographical distance
• Solid attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines