Quality Assurance Auditor

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
• Ov ersees 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 staff
• Represents QC function in Joint Steering Committee meetings with customers
• Supports Regulatory and Customer Audits as needed
• Manages the QC budget process
• Responsible for providing support to the QC Department of the Cell & Gene Therapies Business Unit for certain shared services including Raw Materials, QC Systems, Sample Logistics etc.
• To approve or reject starting materials, packaging materials, intermediate, bulk and finished products
• Responsible to ensure the QC operations comply to cGMP and safety regulations
• Responsible to ensure QC participation in the multidisciplinary customer teams (IPT, JPT) and the global QC work teams
• To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy
• Ensure escalation of non-compliance or ineffective Quality System deployment at site
• Plan resources for QC to support projects and testing in alignment with production activities. To ensure that all necessary testing is carried out and the associated records evaluated
• To lead the method transfer activities for customer projects in Quality Control
• To lead from a QC standpoint audits / inspections by customers and / or regulatory agencies
• To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences
• Drive the timely release of test results and approval of certificate of Analysis to support batch release
• Ensure that product has been manufactured and tested in accordance with c GMP requirements, company SOPs, policies and specifications
• To approve specifications, sampling instructions, test methods and other Quality Control procedures.
• To ensure the qualification and maintenance of QC premises / equipment and appropriate validations are done
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures
• Any other duties as assigned by Site Quality Head

Key Requirements :

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.