Head of Quality Control

Portsmouth, New Hampshire

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Head of Quality Control (QC) leads the Quality Control 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.

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.

Key Responsibilities

  • Develops and executes quality control continuous improvement initiatives for the site.
  • Ensure that the QC organization meets key performance indicator goals. Includes meeting and exceeding internal stakeholder and customer expectations.
  • Oversees raw materials testing, in-process and finished product testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management and QC document management.
  • 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.
  • Performs other duties as assigned.

Key Requirements

  • Bachelor  degree  and/or Advanced Graduate degree (MS/PhD)
  • Preferred area of study:  Microbiology, Biochemistry or equivalent Science Field
  • Extensive experience in a GMP/Professional environment, preferably in biologics.
  • Preferred experience in the pharmaceutical industry.
  • Prior direct supervisory/manager experience, leading large organization structures.
  • Use of Laboratory computer systems
  • Potential previous use of GMP Quality Systems such as: TrackWise, LIMS, DMS
  • Prioritization and problem solving.
  • Direct, control and plan tasks/projects.
  • Excellent communications skills both written and verbal format.
  • Relate to others in a team setting. Able to coach and manage experienced and inexperienced staff
  • Maintain positive attitude and emotional composure in a team environment.
  • Makes quality decisions independently
  • Mentoring and leading direct reports.
  • Able to manage difficult situations (e.g. disciplinary actions, poor performance plans).

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: R16303