We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior GxP Manager
The purpose of the job is:
- Further development and improvement of the existing Quality Management System (ISO 9001:2015 certified) regarding GxP requirements
- Maintenance the GxP-compliant QMS
- Incremental development, management, monitoring and maintenance of GxP relevant processes and procedures (e.g. SOPs, Quality Agreements between contracted parties, validation documents, vendor qualification documents such as an Approved Vendor List, Approved Contractor List, vendor qualification records)
- Maintenance and oversight on appropriate processes and systems for the management and archival of documents and data
- Contributions regarding management of deviations, CAPA management, change management, complaint management, quality risk management/risk assessment and other elements of the Quality System
- Preparation and management of GxP quality management plans and compliance programs
- Provision of information required for Quality Management Reviews, e.g. KPIs, compliance risks, audit updates
- Support of internal audit activities
- Management of inspection readiness activities, and support of client audits and inspections
- Organization and performing GxP training and provision of work guidance regarding GxP requirements
- Leadership and/or participation in contractor/supplier audits
- Responsibility for the GxP vendor management program, e.g. development and management of the audit program
- General tasks regarding QM as part of the corporate QM-Team
- At least Bachelor’s Degree in a life science discipline (Pharmacy, Chemistry, Biology or related discipline)
- Deep knowledge of GxP regulations
- Minimum of 8 years experience in the development and management of GxP Quality Systems in a global pharmaceutical company
- Analytical skills and lateral thinking to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations
- A team player to establish professional relationships and rapport with internal and external peers and higher-level management
- Regulatory understanding, broad-based knowledge of domestic and general knowledge of international regulations associated with GxP
- Fluent in written and spoken English
- Opportunity to conquer exciting and varied challenges alongside an experienced and talented team in a dynamic company
- External business interaction with clients and internal collaboration within the PharmaLex organization
- Broad range of initiatives for personal development and professional training
- A friendly and openminded work environment in a global organization
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Senior Specialist, Human Resources
Agencies only by prior agreement for the specific job opportunity.