International Senior Quality Manager
Location | Munich |
Discipline: | Quality Assurance, Regulatory Affairs |
Job type: | Permanent |
Salary: | £Salary: Highly competitive + Benefits - Depending on experience |
Contact name: | Katie Dunbar |
Contact email: | Katie.Dunbar@rbwconsulting.com |
Contact phone: | 01293584300 |
Job ref: | 21621 |
Published: | almost 3 years ago |
Expiry date: | 20 Jun 2021 11:59 |
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.
Salary: Highly competitive + Benefits - Depending on experience
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