International Senior Quality Manager - Munich, Germany

In a newly created role, my client seek an International Senior Quality Manager to support growth of existing business and preparation for the introduction of ATMP (cell and gene therapies) on to the market.  This role will be responsible for ensuring the quality system is in place and meets the requirements of GDP and will act as RP on the wholesale dealer’s authorisation in Germany.  This role would help establish an appropriate QMS to support any aspects of the GMPs required for the supply of ATMP in Germany.  This role is also an integral part of the International Quality team and will support GDP & GMP activities throughout the EU, including audits and inspections and QMS maintenance.  

Key Responsibilities:

• Maintain and enhance the QMS to support the QP certification of cell and gene medicines
• Ensure WDA accurately reflects the current organisation, and vary where necessary 
• Planning/ Preparation/supporting/hosting for Regulatory inspections 
• Providing front and backroom inspection support, post inspection follow-up with responses and CAPAs
• Manage/Approve/Assess event investigations “deviations” 
• Monitor, assess impact and communicate Regulatory Intelligence information 
• Manage the development, implementation, and maintenance of cGMP quality operational processes for clinical phase/commercial phase cell and gene therapies
• Maintain knowledge of global regulatory requirements for CGT products and ensure compliance 
• Develop solutions to complex quality issues which potentially impact CGT manufacturing and testing to ensure patient safety, as well as compliance with cGMP regulations and quality expectations
• Demonstrated knowledge of current international regulations and guidance associated with CGT
• Ensure that initial and continuous training programs are implemented and maintained for staff involved in the Wholesale dealing operations 
• Coordinate and perform recall operations for sites where acting as RP
• Work with Product Complaints team to ensure that customer complaints are dealt with effectively
• Approving any subcontracting that may impact GDP
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program
• Create/review and approve SOPs and other Quality Documents
• Build strong working relationships with International Supply Chain, Regulatory, Technical Operations and the global quality functions.

Key Requirements:

• Master’s degree and relevant work experience, or Bachelor’s degree in a relevant field, and extensive relevant work experience
• Eligible to act as a Responsible Person in the European Union
• Good understanding of cell and gene therapy quality area – manufacturing or testing 
• Expert knowledge of global GDP/GMP requirements governing oral drug products and knowledge of product manufacturing practices
• Experience working in a bio-pharm development/production environment 
• Experience of working in an international organisation and with other international affiliates, and experience of working within a matrix structure
• Extensive GMP and GDP experience
• Previous GDP/GMP auditing experience with GMP experience
• Ability to learn new information and roll out to the wider audience
• Strong leadership skills with the ability to thrive in a high throughput environment
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Change Management
• Continuous Process improvement
• Strategic thinking / forward thinking / planning
• Ability to design technical documentation
• Fluency in English is required.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.