Director - Head of Quality Control, Biologics

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. 

Job Summary:

The Head of Quality Control (QC) is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.
 

The Head of QC provides a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules and performance requirements.
 

Role will be responsible for Championing operational excellence and innovation as well QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. 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

• Lead the Quality Control Department for the Mammalian Business Unit at Lonza Portsmouth with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics and includes all personnel associated with the department i.e. FTE, interns and contractors

• 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

• Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals

• To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives

• 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