Country Manager – Technical Operations, SOTIO Medical Research Beijing
|Přímý nadřízený:||Chief Executive Office, SOTIO Beijing, Global Chief Operating Officer|
|Místo práce:||Beijing, China|
|Pracovní úvazek:||Full time employment|
Shrnutí pracovní pozice:
Responsible for leading a manufacturing team in Technical Operations department. Directly reports to company local CEO (SOTIO Beijing) and via dotted line to Global Chief Operating Officer (SOTIO Prague).
Technical operations manager is responsible for GMP manufacturing in terms of planning and coordination including the leadership of Manufacturing Supervisors and Manufacturing Associates. He/she is involved in management of selected validations, change control, risk analyses and other GxP related activities. Participates on planning of annual facility shut-down and requalification of GMP facility. With support of technical team he/she ensures the GMP facility is fully operational.
Hlavní činnosti a zodpovědnosti:
- Ensures manufacturing is organized within the agreed rolling forecast per study/project with sufficient product quality and agreed budget,
- Manage the Manufacturing supervisors that report in their daily work and provide strategic vision for the COO/CEO and their teams as well as support them in any staffing-related efforts,
- Prioritizes each project goals as assigned while continually developing the team,
- Serve as a key member of the local management team and participate in setting company operating goals,
- Knows and follows the principles of Current Good Manufacturing Practice (cGMP), Global Quality Policy and other internal company regulations and guidelines,
- Ensures training of all manufacturing staff to be efficient and streamline processes,
- Manage and supervise all company agreed projects from the manufacturing perspective, including staffing and personnel allocation, budgeting, equipment maintenance, timelines and delivering projects on time and communicate at beginning, during and end of projects, all with company CEO/COO,
- Authorizes work instructions (WIN) and standard operating procedures (SOPs) related to production and ensures their proper implementation on time,
- Ensures that production records are precisely evaluated and handed over to QA in time,
- In cooperation with Global Process Development participates on implementation of any newly agreed project into GMP manufacturing,
- Ensures proper maintenance of clean room facility and equipment related to manufacturing,
- Deliver weekly operation reports for local management meetings and monthly operation reports for global company management meetings,
- Communicate with Global COO on weekly basis.
Kompetence, dovednosti a kvalifikace:
- University degree in biotechnology, biology, pharmacy or biochemistry,
- Fluent Czech,
- Upper Intermediate or preferably advanced knowledge of English with solid communication skills,
- Proven experience in rapid-growth environment of cell and/or gene therapy field,
- Appropriate communication and leadership skills,
- Project Management skills,
- MS Office – Word, Excel, Project, Windows, e-mail, Internet,
- Ability to travel.
Napište nám (firstname.lastname@example.org)
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