Supervisor, QA Technical Projects
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.
Lonza in Walkersville, MD has an exciting opportunity for a Supervisor, QA Technical Projects. This successful candidate will be accountable for direct management/oversight of QA Specialists within the Quality department. Manages and maintains site compliance to Quality Systems, ensuring compliance with ISO/GMP requirements and other regulatory guidance as appropriate. Provides oversight of Device History Records (DHR) and Master Batch Record (MBR) review. Provides oversight for compliance of CAPA and investigations. Leads asset-specific adhoc projects and supports asset-specific gap analyses/mitigation efforts. This role is also intended to serve as primary backup to QA Senior Manager.
- Owns/develops/maintains a robust QA program responsible for for oversight of the company’s compliance with ISO/cGMP quality system requirements and other regulatory guidance.
- Directly manages QA Specialists with minimal oversight
- Oversees quality support to operations and quality control staff to address compliance related concerns.
- Provides oversight for compliance of CAPA and investigations, OOS and deviations.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Makes independent quality-related decisions based on regulatory and compliance knowledge and provides independent quality support to project teams.
- Audits internal quality system elements in manufacturing and operational support areas.
- Reviews and approves deviations, investigations, change controls, audit observations, and CAPAs.
- Reviews and approves Batch Records, as backup to OTF/Clearance team
- Hires, trains, and evaluates department personnel. Conduct employee performance evaluations
- Represents the QA department in internal/external audits and inspections
- Leads asset-specific continuous improvement and adhoc projects and supports asset-specific gap analyses/mitigation effots.
- Performs other duties as assigned
- Bachelors degree in life science field preferred and minimum 5 years quality experience in a GMP/FDA regulated environment
- Prior supervisory experience
- Strong technical writing and review skill set
- Innovative, proactive, and resourceful
- Ability to guide, coach, mentor others and lead/empower successful teams
- Ability to embrace a Quality Culture and serve as an example Quality leader
- Ability to be self-accountable for deliverables and meet established deadlines or notify manager of obstacles preventing meeting deadlines. Can independently work to overcome such obstacles.
- Quality and continuous improvement mindset
- Ability to thrive in a fast-paced environment
- Capable of collaborative project planning and execution
- Intensive regulatory knowledge, specifically cGMP’s and other applicable regulations (e.g. EU, ISO) as they relate to the Manufacturing and Quality Unit requirements
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Trackwise Quality Management System)
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
- Experience interacting with FDA or other regulatory agencies strongly preferred
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.