Demo

Head of QA

Lonza Biologics Porriño SLU
Rye, NY Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/9/2025

Associate Director - Head of Quality Control, Cell Therapy

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Location : United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across five continents. 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, and their ideas genuinely improve the world.

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. This role champions continuous improvement initiatives resulting in strong regulatory compliance and high customer satisfaction, while contributing to the site’s growth strategy, including planning, budgeting, and safety.

Key Responsibilities :

  • Develops and executes the QC strategy for the site, ensuring 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.
  • Manages the QC budget process.
  • Performs 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.
  • Strong prioritization and problem-solving skills.
  • Ability to direct, control, and plan tasks / projects.
  • Excellent communication skills in both written and verbal formats.
  • Ability to relate well to others in a team setting, actively listening and seeking to understand and to be understood.
  • Maintain a positive attitude and emotional composure in a team environment.
  • Timeliness in completing assigned tasks.
  • Ability to make quality decisions independently and with guidance from the Director.
  • Experience in mentoring and leading direct reports.
  • Able to deliver difficult messages to staff (e.g., disciplinary actions, poor performance plans).
  • Every day, Lonza’s products and services positively impact millions of people. For us, this is not only a privilege but also a responsibility. We respect and protect our people and our environment, believing that success must be 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 around the world.

    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 a disability, protected veteran status, or any other characteristic protected by law.

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