Lonza
Associate Director, Head of Quality
This job is now closed
Job Description
- Req#: R69271
Quality Assurance
• Oversee QA operations, including batch release, complaint handling, and cGMP compliance.
• Represent the site during customer audits and regulatory inspections.
• Collaborate with cross-functional teams to ensure quality standards in manufacturing.
Quality Control
• Lead QC functions covering Raw Material, Analytical, Microbiology, Biochemistry, and Environmental Monitoring.
• Ensure timely testing and release of results, including Certificates of Analysis.
• Develop and implement QC strategies aligned with business goals.
Quality Compliance
• Implement and maintain procedures in alignment with global and national cGMP regulations.
• Translate global quality standards into site-level policies and practices.
• Maintain site readiness for audits and certifications.
Customer Interface
• Ensure all quality related customer complaints are investigated and handled in time.
• Develop insights that can be used to enhance customer satisfaction or other metrics.
• Identify when company and customer interest may not align and seeks effective solution to resolve or escalate.
Regulatory Affairs
• Keep the site updated with the recent applicable regulations.
• Coordinate with all functions to ensure site compliance with the latest requirement and monitor execution of the related action plan.
Strategy & Continuous Improvement
• Develop long-term and annual quality plans.
• Lead quality improvement projects in line with the Operational Excellence strategy.
• Drive strategic initiatives to strengthen quality systems and processes.
Resource Planning
• Manage department budgets, staffing, and scheduling.
• Ensure adequate resources are available to meet business and regulatory demands.
• Prioritize quality initiatives to meet critical timelines.
People & Leadership
• Build and lead a high-performing quality team across QA, QC, and Compliance.
• Implement team development, training, and succession plans.
• Foster a compliant, efficient, and collaborative team culture.
Qualifications
• Degree :Master degree,
• Field of Study: Pharmacy, Chemistry, Biotechnology, Engineering
• English: Business Fluent
• Highly Experienced (10+ years) in Leading Senior Quality Function.
• People management skills
• Strong communication skills (vocal/written/presentation)
• Strong execution skills (ability to plan and take activities to closure)
• Project management skills
• Strong analytical skills
About the company
Lonza Group is a Swiss multinational chemicals and biotechnology company, headquartered in Basel, with major facilities in Europe, North America and South Asia.
Notice
Talentify is an Equal Opportunity Employer. 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.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.