Associate Director, Quality Systems - US02 Lonza Biologics Inc.

Today, Lonza is a global leader in life sciences operating across three 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.

The Associate Director of Quality Systems ensures that the GMP systems and controls in place at the site meet Global Quality Standards and applicable regulatory requirements.  S/he liaises with Global Quality leadership and is a conduit for driving harmonization and alignment within the biologics network.  Additionally responsible for ensuring that significant quality concerns are documented within the Quality Management System (QMS) and for maintaining systems that prompt the appropriate mitigation/remediation actions. 

This position typically has oversight of direct reports and will assign resources and priorities, ensure adequate training, coaches and develops staff, evaluates performance, and supports overflow of tasks across Quality as needed.  The Director of Quality Systems is a member of the Senior Quality organization and participates in decision making for escalations and communication of decisions at the site.

Key Responsibilities:

• Partners with the Site Quality Head and Global Quality leadership to propose approaches in executing the strategic quality goals and ensuring alignment across the network.
• Oversees the hiring process for Quality Systems personnel, provides performance feedback, coaches, mentors and supports career development.
• Sets and communicates direction for Quality Systems teams that is current with industry trends, guidelines and regulations.  Responsible to ensure progress and completion of opportunities and continuous improvement initiatives.
• 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.
• Participates in the hiring process, provides performance feedback, coaches, mentors and supports career development.
• Designs and implements Quality System improvements while ensuring high level internal / external customer support.
• Acts as a point of escalation for QA staff and customers.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings. 
• Attends Site Quality Council and Lot Disposition meetings.
• Provides TrackWise Quality System site administration, i.e. maintain personnel records, site user accounts, provide user support/ helpdesk/ troubleshooting.
• Manages and tracks Key Performance Indicating Quality Metrics including compilation of monthly/quarterly deviation trending reports for site management.
• Owner of Site Quality Council meeting.
• Product Quality Review (PQR) administration.
• Supports Customer audits and/or Regulatory inspections.
• Performs other duties as assigned, including reviewing and approving various documents (e.g. Product Quality Reports, Quality Agreements, Deviation Reports, filing reviews) and lot disposition.

Key Qualifications:

• Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results
• Mentoring and leading direct reports
• Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans)
• Use of Microsoft Suites (Word, Excel, PowerPoint)
• Advanced use of Enterprise GMP Quality Systems such as: TrackWise, DMS LIMS, ELN (iLAB), MODA, CDS (Empower)
• Able to interpret data
• Perform assigned, complex, and/or varied tasks
• Prioritization and problem solving
• Direct, control, and plan tasks/projects
• Excellent communications skills both written and verbal format
• Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
• Maintain positive attitude and emotional composure in a team environment
• Timeliness in completing assigned tasks
• Makes quality decisions independently and also with guidance from Site Quality Head

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.