The Technical Manager is responsible for the managing tasks associated with Pharma Quality System implementation for CMO OU. This includes following established business processes and tracking to activities in the organization.
In addition, the technical manager is responsible for operation of the Change Control and Deviation/CAPA Management Systems in External Quality Operations. Working with Stakeholders, this position will manage the process by which Genentech’s evaluation of changes and deviations is performed. This position will be responsible for the operation, documentation and evaluation resulting from Review Boards (CAPA Review Board, Change Review Board and Quality Review Board). The Technical Manager will review CMO documentation and relevant assessments and will work with Site Managers, the External Review Boards, and other business unit to
ensure that changes/deviations/CAPAs are evaluated to a consistent standard and in accordance with applicable policies and procedures.
In addition, the Technical Manager will support execution of Quality Systems in the department and represent cross function teams.
- Genentech experience is a must.
- Working in Change Control system a must
- Knowledge of Discrepancy and CAPA systems are desirable
- Trackwise, Excel, Powerpoint, SAP and Word experience required
- Sound knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate) in order to evaluate product release is necessary. Sound knowledge of Quality Systems is essential and understanding of cGMP regulations.
- Strong time management skills and ability to prioritize own work.
- Experience reviewing change and deviation/CAPA records.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and negotiation skills.
- Outstanding interpersonal, influence, initiative, task management, and conflict management skills.
- Ability to manage multiple, changing priorities in a fast-paced environment is essential; strong attention to detail required.
- At least 8 years pharmaceutical experience with biotech/small molecules is required; experience in manufacturing is desired.
- At least 4 years direct experience in quality assurance for pharmaceutical operations is strongly preferred.
- BS or BA in a relevant scientific discipline or equivalent and demonstrated working knowledge of Quality Assurance and manufacturing principles.