Associate Director, Quality Systems
Lonza
- Portsmouth, NH
- Permanent
- Full-time
- 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.
- 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