Manager Quality Engineering 80-100%

The Manager, Quality Engineering at the Janssen Supply Chain Site Schaffhausen, CH will be responsible for providing Quality oversight of qualification activities for the manufacturing and laboratory equipment for the site, including commissioning, qualification, computer systems validation (CSV) per established local and global standards. 

The person will oversee the daily activities of the quality engineering team which consists out of 10 individuals. The qualified candidate for this position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self- motivated to take action, and have excellent written and verbal communication skills.

Manager, Quality Engineering (f/m/d), 80-100%

Responsibilities

Manage the Quality engineering resources and allocate across sustaining engineering and NPI projects to support business objectives from a QA perspective.
Supervise a team of quality engineers overseeing QA activities in one or more of the following disciplines:

• Computer System Lifecycle Documents, risk assessments and strategies
• User Acceptance Testing / Installation Qualification / Operational Qualification protocols/ deviations/ reports
• Commissioning and Qualification Lifecycle Documents, risk assessments and strategies
• QA Review and Approval of non-conformances, CAPAs, Change Controls
• Calibration and maintenance activities, as applicable
• Conduct, Support investigations and CAPAs
• Assessment and Approval of Change Controls
• Review and approval of compliance records, procedures and other documents as required 
• Periodic Review of Equipment

Responsible for team performance and development, provides guidance and mentorship and effectively onboard new personel.

Partner with Engineering, Operations, and further departments to assure all sustaining engineering and NPI quality deliverables are met in accordance with all regulatory standards within cost, quality and schedule requirements.

Communicate effectively at all levels within Quality as well as cross functionally with departments such as Engineering and Operations.

Ensure that all relevant aspects of C&Q Programs are compliant to applicable regulations and standards.
Identifies opportunities for continuous improvement and drive standardization across the C&Q process.
Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
Responds to requests from audits and inspections from health authorities, customers and corporate compliance