Global Head of Quality - Bioscience
United States, Walkersville (Maryland)
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 Global Head of Quality, Bioscience is responsible for all Quality and Regulatory aspects related to Lonza’s sites (Walkersville, Cologne, Verviers, Wayne, Raleigh-Durham, Copenhagen & Rockland) within the Bioscience organization. Ensuring development and training of a Quality strategy that delivers measurable results for the business by generating process improvements, building customer and client satisfaction. Setting the strategy of the Quality function, developing and maintaining Quality standards and guidelines. Escalating issues in an open and timely manner and taking leadership for their resolution. Drives efficiency of the QA/QC & regulatory approach across the portfolio
- Providing leadership for all Quality and Regulatory activities related to the site network within Bioscience. Plans, directs and controls all quality requirements
- Sets the strategy of the quality function for the sites, developing and maintaining Quality Assurance standards, guidelines and developing policies and procedures to ensure the quality of work in all disciplines.
- Identifies and resolves problems through senior managers by implementing project-based solutions which deliver improved business performance against critical quality factors. Detect potential gaps and initiate corrective and preventive actions (continuous improvement).
- Oversees the trainings of overall quality specifications and standards. Trains for a quality oriented culture of the organization.
- Responsible for the achievement of recognized local and international standards.
- Responsible for promoting recognition of company quality programs among customers, as well as developing and implementing employee communication and training programs in connection with the company’s quality objectives, strategies and processes.
- Leads a team of Quality Site Heads - creating active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
- Make sure that decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations.
- Active member of Lonza Global Quality Leadership Team
- Quality partner to the Bioscience Leadership Team
- First contact for the respective sites for any Quality and Regulatory related topic. Ensure that new clients receive appropriate and complete information regarding Lonza’s quality systems
- Making sure quality agreements with customers and suppliers are in place. Ensuring that customers have appropriate licenses and are authorized to purchase APIs and corresponding services.
- Supporting the sites in the collaboration with authorities and customers which are linked to strategic growth projects.
- Providing expertise and coaching, assisting sites and their teams for policies, procedures and specifications.
- Ensuring required Quality resources (and proper expertise) are available and effective at the sites.
- Contributing to the development and maintenance of global and local quality systems in line with current regulatory requirements. Ensure collaboration with other Lonza Quality and Regulatory functions with the goal to share best practices and to have one global quality system, where applicable.
- Supporting the movement away from traditional Quality compliance practices towards new frameworks for the regulatory oversight of manufacturing quality that are based on quality systems and risk management approaches (cGMP in the 21st century).
- Closely follow industry trends and engage in industry associations to develop innovative future manufacturing concepts (e.g. BPOG)
- Substantial experience in a regulated pharmaceutical industry including: manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs.
- Experience of sterile manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.
- Proven management experience in an EMA / FDA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Leadership role in operations readiness including the onboarding and training of new staff – both quality and operations.
- Experience in managing USFDA, EMA, MHRA Audits etc.
- Experience hosting and managing inspections and audits.
- Considerable experience in implementing quality initiatives experience at a senior level is required.
- Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, DMS, LIMS, SAP etc.).
- Working knowledge of modern approaches to compliance such as cGMP in the 21st century.
- Working knowledge of modern quality tools such as risk based approaches – FMEA, statistical process control, design of experiments and Six Sigma.
- Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities
- Strong verbal and written communication skills (English and German).
- Effective influencing skills. Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
- Strong collaborative mindset.
- Proven ability to lead, mentor and coach direct reports and teams with or without direct line responsibility.
- Strong organizational skills, ability to balance multiple priorities simultaneously.
- Ability to solve problems, understanding details and strategic picture, providing practical solutions. Strong analytical and investigative skills.
- Strong project management skills.
- Strong experience in cGMP Manufacturing of chemical and biological APIs.
- Understands the risk based approach recommended by Lonza’s planning for quality system.
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.