Jobbeschreibung
CordenPharma is one of the leading Contract Development and Manufacturing Organizations (CDMO) and develops and produces active pharmaceutical ingredients, medicines and associated packaging services on behalf of its customers as a “full-service” service provider. The group employs around 3,000 people.
Our network in Europe and the USA offers flexible and specialized solutions across five technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology and small molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the benefit of patients.
CordenPharma International (CPI) acts as the management company of the CordenPharma Group. In addition to the Executive Leadership Team, CPI has central functions such as Sales & Marketing, Legal, HR and Corporate Development, which work for the CordenPharma Group across locations and at an international level.
Global Quality Business Process Manager (m/f/d)
- Frankfurt am Main
- ASAP
- Full-time
- Permanent
- Global Quality Business Partner focused on the Quality Management of IT System implementation projects and for the Lifecycle Management of Corporate GxP IT Applications.
- Subject-Matter Expert within the CordenPharma network regarding compliance with 21CFR Part11, GMP Annex 11 and GAMP5.
- Development of Design Requirements followed by Validation and Testing strategies in a GxP environment for new Electronic Business solutions.
- Evolvement and continuous optimization of the Global Validation and Lifecycle approach and its presentation to regulatory authorities and external / internal customers during inspections and audits.
- Supervision of cross-functional teams within the CordenPharma network during execution of new and ongoing Validation and Qualification activities for Computerized Systems.
- Close collaboration with CordenPharma Site Quality and IT teams for locally implemented electronic systems and support cost-efficient solutions.
- Review and implementation of IT quality-related processes, standards and systems.
- Execution of internal and external audits and responsibility for supplier management of IT service providers.
- Master's degree in IT, Pharmaceuticals, Engineering, Life Sciences or a similar field.
- Profound knowledge of FDA- / EU-Guidelines, including computer system validation, quality risk management and data integrity.
- Long-term professional QA experience in supporting IT applications in a global GxP environment throughout the whole lifecycle of an application, preferred in a CDMO business.
- Confident handling with electronic systems, ideally to be familiar with Trackwise, Labvantage, SAP, eCTD Manager.
- Fluent communication in English.
- Excellent interpersonal and communication skills.
- Highly self-motivated with “Can do” mentality and a strong sense of ownership.
- Flexibility and willingness to travel (< 10 %).
- 30 days of vacation
- Dynamic and exciting work environment
- Cafeteria
- Accessible Workplace
- Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative