Quality Assurance Auditor

4 days ago

South Hampton, United States Lonza Full time
Quality Assurance Auditor at Lonza summary:

The Quality Assurance Auditor oversees the Quality Control (QC) function at Lonza, ensuring quality and delivery align with internal and customer expectations. This role involves developing and executing QC strategies, managing budgets, and championing continuous improvement initiatives while fostering a positive culture within the QC organization. A key focus is on enhancing regulatory compliance, customer satisfaction, and employee retention through effective leadership and communication.

United States, Portsmouth (New Hampshire)

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 you to be part of.

The Associate Director -Head of Quality Control (QC) leads the QC function at the site, implementing a strategy that supports the quality and financial goals of the company. Champions continuous improvement initiatives resulting in a strong regulatory compliance profile and high customer satisfaction. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site’s growth strategy, including planning, budgeting, and safety.

Key Responsibilities:
  • Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations.
  • Oversees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management.
  • Develops and executes continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals.
  • Works closely with Program Management, Quality Assurance, Manufacturing Asset leadership, and customers to support project teams throughout the product lifecycle.
  • Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff.
  • Manage the QC budget process.
  • Perform other duties as assigned.

Key Requirements:
  • Bachelor's degree in a Science or Engineering field.
  • Significant leadership experience in Quality. CDMO experience preferred.
  • Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results.
  • Able to interpret data and direct actions based on insights.
  • Prioritization and problem solving.
  • Direct, control and plan tasks/projects.
  • Excellent communications skills both written and verbal format.
  • Relates well to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff.
  • Maintain positive attitude and emotional composure in a team environment.
  • Timeliness in completing assigned tasks.
  • Makes quality decisions independently and also with guidance from Director.
  • Mentoring and leading direct reports.
  • Able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans).

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.

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.

Reference: R63846
Keywords:

Quality Assurance, Quality Control, Regulatory Compliance, Continuous Improvement, Life Sciences, Project Management, Data Integrity, Team Leadership, Manufacturing, Microbiology

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