Head of Quality
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. 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. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
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 and ensure maximum efficiency. Ensure systems are extraordinary and 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, policies, and procedures to ensure compliance with relevant ISO standards, corporate policies, and other regulatory body regulations and guidelines.
- Coordinate with industry partners to address product quality matters, customer happiness levels, and regulatory authority interaction. Lead all partner audits and inspections and action programs in response thereto.
- Serve as the company Quality guide, providing solid, actionable Quality support to Kingston Operations, R&D, and functions as requested.
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 risk management methodologies like FMEA, FTA, and ISO 14971.
- Quality Assurance and Control: Expertise in quality assurance principles, including quality planning, control, assurance, and improvement.
- Statistical Analysis: Strong analytical skills and the ability to interpret statistical data to identify trends and root causes.
- Problem-Solving: Excellent problem-solving and decision-making skills to address quality issues and implement corrective actions.
- Leadership: Strong leadership and communication skills to lead a team, influence cross-functional teams, and effectively connect with all levels of the organization.
Experience:
- Proven track record: Experience in the medical device industry, preferably in a leadership role.
- Regulatory Experience: Experience interacting with regulatory agencies and successfully leading audits and inspections.
- Team Leadership: Proven ability to build, lead, and motivate high-performing quality teams.
- Project Management: Experience leading sophisticated projects, including product development, regulatory submissions, and quality initiatives.
Personal Qualities:
- Diligent: Demonstrates strong attention to detail and accuracy.
- Achievement-focused: Prioritize delivering tangible outcomes.
- Collaborative: Ability to work effectively with cross-functional teams.
- Adaptability: Flexibility to adapt 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, FDA regulatory requirements applicable to FDA regulated products.
- Current industry trends and the ability to use the latest technologies.
- Computer software skills, organization, record-keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills.
- Carry out pragmatic problem solving with purpose and vitality and advise Management of compliance or quality issues. Report regularly on quality and compliance.
- Diplomacy, negotiation skills, written and verbal communication, team building skills, independent work skills, strong work ethic, mentoring, and delegating skills with collaborator groups 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 or equivalent experience preferred.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
