Manager, Quality Assurance Operational Excellence

Lonza America Inc
Tampa, FL
Full-time
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Join the Lonza Team

Hiring for Manager of Quality Assurance Operational Excellence

Today, Lonza is a global leader in life sciences operating across three 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.

The Digital Commerce organization at Lonza's Capsule & Health Ingredients (CHI) is driving a digital transformation across the division and is seeking talented, entrepreneurial thinkers to join the team.

Summary

The Manager of Quality Assurance Operational Excellence is responsible for leading the efforts to generate OE strategy, to identify and develop systems and support for ongoing Quality site efforts : process improvement, daily management system, metrics and culture.

Key Accountabilities :

  • Plan, lead, drive and execute business critical improvement projects to deliver successful results using Lean / DMAIC approach.
  • Achieve goals through the application of continuous improvement and contribute to shaping Tampa Strategy development and delivery, organizational development and culture leadership.
  • Act as a subject matter expert for the site by coaching others in the philosophy, methods, tools and techniques of process improvement to increase the capability of the business to respond to problems
  • Coach teams to establish performance measurements and process control plans to monitor project results and drive sustainability.

Communicate project progress and promote project achievements to maintain awareness of improvement activity on the site, across the network and with corporate leadership.

  • Implement and maintain adequate measurements and control systems to identify improvement opportunities / needs.
  • Develop OE strategic plans and deployment including metrics setting and reporting.
  • Partner with SLT, global OE, and corporate leadership on driving Lean Six-Sigma projects to increase productivity and enhance effectiveness of operation processes and systems.
  • Participate and contribute to the global OE network and share best practices.
  • Provides Quality leadership to ensure that QA activities, manufacturing and packaging operations are conducted in compliance with SOPs, cGMP standards and FDA regulations.
  • Creates, develop, implement and maintain departmental systems that foster a culture of quality and continuous improvement focused on value to the customer.
  • Disseminates Quality best practice throughout the organization through training, presentations, etc..
  • Participate in internal, client and / or regulatory audits.
  • Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
  • Participates in deviation investigations, root cause analysis, impact assessments, and corrective or preventive actions.
  • Development, implementation and management of all quality systems and activities
  • Establish, maintain, trend and report Quality KPI and metrics.
  • Lead / Participate in Management Review, Quality Review Board, Deviation Review Board and Change Review Board.
  • Lead / Participate in Risk Analysis / Risk Management activities.
  • Other tasks as assigned by Head of Quality

Minimum Education Level Required :

Bachelors

Preferred Field of Study :

Science

Minimum Years Required Experience :

Preferred Field of Experience :

Pharma cGMP

  • Minimum Green Belt Certification
  • Black Belt Certification 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.

Compensation for the role will depend on a number of factors, including the location of the successful candidate, qualifications, skills, competencies, experience, and job-related knowledge.

Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

10 days ago
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