Associate Director, Quality Assurance (Biotech)
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 to be part of.
As a key member of the Quality Leadership Team, this role will provide oversight and coordination of strategic asset projects by collaborating closely with Operational Excellence and Site Operations Project Management. You will work with both departmental and cross-functional teams to develop a pipeline of projects sought at improving processes and delivering value to the organization. Partnering with Engineering, you will help develop CAPEX and lump sum arguments and project charters, while leading medium to large projects or mentor team members in handling smaller to medium-sized projects.
You will drive continuous improvement through the Lonza Business Management System (LBMS), including the development of Key Performance Indicators (critical metrics). Additionally, you will support asset strategy development and supply to organizational growth and cultural leadership, while collaborating with Operations Leadership to evaluate capacity, resources, and personnel requirements.
Key responsibilities:
Department Project Portfolio Management
Collaboration with Quality Management team, departmental & cross-functional peers to build pipeline of projects bringing value to the organization (linked to compelling business needs).
Collaboration with OE and Site PM to drive use of appropriate project management tools, ensure appropriate alignment/prioritization across various functions & understanding of project resource needs.
Partnering with Engineering and Finance, develop or support development of compelling reasons for CAPEX requests.
Ensure flow of information and communication of key data on project portfolio
Harmonization and Innovation
Drives Harmonization of Quality processes across the Bioscience business unit and works closely with the Bioscience operation strategy functions.
Drives LBMS within Quality; Leads development of & handles execution of the Lean Maturity Assessment (LMA) roadmap.
Drives capability building of project leads on project management skills and Lean Elements.
Develops Key Performance Indicators (critical metrics) for Quality, supports development of lower-level critical metrics ensuring alignment at various tier meetings.
Project Management
Responsible of deliverables of assigned projects in respect of cost, scope and timelines and is responsible for manage mitigation actions.
Serves as initiation project lead for new technologies.
Leads medium to large projects partnering with Engineering, MSAT, as applicable.
Supports asset strategy development and delivery, organizational development, and cultural leadership.
Supports peers and team in the partnership with Operations to ensure business needs are met.
Perform other duties as assigned.
Key requirements:
Bachelor's degree or equivalent experience in Biological Sciences, Biomedical Engineering, Chemical Engineering, or a related field, with a minimum of 7 years of directly relevant manufacturing experience.
Expertise in large-scale manufacturing operations, including aseptic final product filling, kitting, labeling, powder blending, and liquid manufacturing (vials, bags, bottles), with a strong understanding of current Good Manufacturing Practices (cGMP).
Confirmed ability to develop and handle budgets, assess capacity, and resource needs, and build compelling cases for CAPEX projects.
Exceptional organizational skills with the ability to prioritize contending demands and lead initiatives to successful, timely completion.
Strong leadership abilities, combined with excellent communication, technical writing, and interpersonal skills.
Committed to following safety protocols, ensuring the safety of both you and the team. Actively participates in required health and safety training, promotes a safety-conscious work environment, and promptly reports any potential or actual accidents or injuries. Must adhere to all company and site safety policies.
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.
The full-time base annual salary for this onsite position is expected to range between $160,200.00 and $186,900.00. Compensation for the role will depend on a number of factors, including the successful candidate's qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.
