Head of Quality

Head of Quality

Today, Lonza is a global leader in life sciences operating across five continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers, with their ideas genuinely improving the world.

Lonza AG in Kingston, ON, Canada, is seeking a Head of Quality to oversee and influence the quality and regulatory landscape at our site. This role is crucial in maintaining standards of quality, regulatory compliance, and continuous improvement. The ideal candidate will join a motivated team, working together towards magnificent execution and outstanding outcomes!

Responsibilities:

• Implement improvement initiatives to drive Quality programs: Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, efficiency, budget control, and profitability.
• Develop, implement, and supervise Quality programs: Ensure compliance with relevant ISO standards, corporate policies, and other regulatory body regulations and guidelines.
• Coordinate with industry partners: Address product quality matters, customer happiness levels, and regulatory authority interaction. Lead partner audits and inspections and manage action programs in response.
• Serve as the company Quality guide: Provide actionable Quality support to Kingston Operations, R&D, and other requested functions.

Key Requirements:

• Deep understanding of Quality Management Systems (QMS): Extensive knowledge of ISO 13485, 21 CFR Part 820, and regulatory standards.
• Technical Expertise: Strong background in engineering or a scientific field, with a focus on medical device design and manufacturing processes.
• Regulatory Affairs: In-depth knowledge of FDA regulations, EU MDR, and other international regulatory requirements.
• Risk Management: Proficiency in methodologies like FMEA, FTA, and ISO 14971.
• Quality Assurance and Control: Expertise in quality planning, control, assurance, and improvement.
• Statistical Analysis: Ability to interpret statistical data to identify trends and root causes.
• Problem-Solving: Excellent skills to address quality issues and implement corrective actions.
• Leadership: Strong skills to lead a team and influence cross-functional teams.

Experience:

• Proven track record: Experience in the medical device industry, preferably in a leadership role.
• Regulatory Experience: Experience interacting with regulatory agencies and leading audits and inspections.
• Team Leadership: Ability to build, lead, and motivate high-performing quality teams.
• Project Management: Experience leading projects, including product development and regulatory submissions.

Personal Qualities:

• Diligent: Strong attention to detail and accuracy.
• Achievement-focused: Prioritize delivering tangible outcomes.
• Collaborative: Ability to work effectively with cross-functional teams.
• Adaptability: Flexibility to changing priorities and regulatory requirements.
• Integrity: Strong ethical principles and commitment to quality and compliance.

Solid Understanding of:

• Expert knowledge of GxP, ISO Standards: Applicable to FDA regulated products.
• Current industry trends: Ability to use the latest technologies.
• Computer software skills: Organization, record-keeping and planning skills, budget preparation, and time management.
• Pragmatic problem solving: Advise management of compliance or quality issues.
• Diplomacy and negotiation skills: Strong work ethic, mentoring, and delegating skills in a matrixed organization.

Education Requirements:

• Bachelor's Degree: In Life Sciences, Engineering, Quality Management, or a related field, or equivalent experience. Master’s degree preferred.

Every day, Lonza’s products and services positively impact millions of people. We respect and protect our people and our environment, achieving success ethically.

People come to Lonza for the challenge and creativity of solving complex problems in life sciences, with the satisfaction of making a meaningful difference.