Manager, Quality Systems - Document Control
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 QA Manager-Documentation Control role manages the QA Documentation Control team and program for Lonza Houston, including documentation and records life cycle management, administration of electronic Documentation Management System (DMS) and controlled documents issuance activities. In addition, is the subject matter expert for the interpretation and application of Lonza policies and procedures with regards to GMP documentation. Serve as the site local administrator and representative for document management systems within the Lonza network. Support other quality systems such as: deviations, CAPAs, audits, change controls and training, as needed.
- Manages and oversees all documentation control program responsibilities: issuing controlled documents logbooks/lab notebooks, document change requests process, DMS workflows, record archival, etc.
- Serves as the main point of contact for Houston QA Document Control and manages the documentation control team.
- Local system owner and system administrator of the Electronic Document Management System (Documentum) responsible for site level system configurations, setting up new user accounts and troubleshooting end user issues.
- Trains and assists other employees on DMS use.
- Provides direct supervision of QA Document Control team members. Coach, teach, train and develop employees through 1:1 meetings, performance review, and career planning activities. Support recruiting, staffing, hiring, onboarding, promotion and remediation of employees.
- Decipher resource needs and overall department direction to onboarding actions such as request for new hires or contractual staff
- Develops and implements process improvements initiatives. Author/revise relevant procedures as needed. Develop and deliver training regarding departmental processes and system changes
- Manages the off-site storage process for archiving and retrieving records. Serve as the site administrator of the Iron Mountain electronic system
- Oversee the retention schedule of internal and external stored records to ensure records are maintained and/or destroyed according to the retention policy
- Supports customer audits and inspections as needed.
- Develop presentations for senior leadership to monitor and report Document Control metrics. Analyze such metrics to implement corrective actions to remediate bottle necks and streamline processes
- Performs the Quality Assurance review and approval of the following quality systems records: change controls, deviations/ investigations, CAPAs and controlled documents for Document Control
- Bachelor’s Degree in Life Sciences or Engineering
- Bio/Pharma Industry
- Prior supervisory experience required
- Experience within a cGMP environment and related QA field and regulations
- Project Management Skills
- Problem Solving Tools
- Lean/Six Sigma methodologies
- Technical Writing, Organization skills, Communication Skills,
- Database and spreadsheet, Microsoft Office applications, TrackWise, Learning Management Systems (LMS), Document Management Systems (DMS), SAP
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.