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Production Site Manager
hace 3 meses
OVERVIEW
Job Title:
Production Site Manager
Reports to:
OBI General Manager
Department:
Production
Direct Reports: 1-2
Location:
Niño Jesús Hospital, Madrid, Spain
FLSA Category:
Full-Time; Non-Exempt
Compensation/Salary:
D.O.E.
DUTIES/RESPONSIBILITIES
- Responsible for ensuring the highest level of compliance while working under GMP guidelines.
- Oversee the setup of the site, including but not limited to:
- Maintaining a close connection with the global OMPUL and GMP translation teams
- Managing relevant GMP translation workstreams and activities
- Participating in the establishment of QMS; documenting, drafting, and reviewing.
- Oversee all manufacturing and support activities, including but not limited to:
- Manufacturing
- Cleaning
- QC
- Warehouse
- Act as the primary point of contact with various teams and individuals, including but not limited to hospital research assistants, local/central QA teams, and local engineering/maintenance teams.
- Support the site team with training, qualifications, operations, and personnel.
- Proactively support production and QC initiatives if needed.
- Provide technical support and maintain a high level of data integrity
- Regularly communicate with various teams, including QA, and address any issues as they arise.
- Respect, acknowledge, and maintain the highest levels of safety throughout the site.
REQUIREMENTS
- Bachelor's degree in a scientific discipline or related field is required; an advanced degree (e.g., Master's, Ph.
- Minimum four years of GMP experience with a focus in Aseptic Practice
- Indepth knowledge of cell cultures and analytical methods.
- Ability to train, lead, and manage various sizes of teams.
- Excellent problemsolving and decisionmaking skills, with the ability to navigate complex issues.
- Effective communication (both oral and written) and interpersonal skills, with the ability to interact with stakeholders at all levels of the organization.
- Proactive, resultsoriented mindset with a demonstrated ability to drive change and deliver highquality results within established timelines.
- Strong leadership qualities, with the ability to remain organized, reliable, and independent.
- Ability to work under pressure and constantly adjust to the demands of projects.
- Proficient in Microsoft Office (Excel, Word, PowerPoint), ERP, and HVAC systems
- Fluency in English and Spanish; additional language skills would be a plus.
INTERESTED?
ABOUT US
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platforms, with the ultimate goal of providing life changing treatments at the Point of Care to large numbers of patients at low cost.
