QC Director, Head of Quality Control

United States, Portsmouth (New Hampshire)

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 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.

Key Responsibilities

  • Partners with the Site Quality Head, Site Leadership Team, and Global Quality functions in executing the strategic goals of the company.
  • Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals.
  • 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.
  • Works closely with Program Management, Quality Assurance, Manufacturing Asset leadership, and customers to support project teams throughout the product lifecycle.
  • Attends Site Quality Council (monthly) and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board
  • Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues
  • Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff.
  • Represents QC function in Joint Steering Committee meetings with customers.
  • Supports Regulatory and Customer Audits as needed.
  • 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).

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: R42145