|Location||Paris, Paris, Île-de-France Region|
|Discipline:||Quality Assurance, Regulatory Affairs|
|Salary:||£Salary: €70,000 - €82,000 Per annum + Great benefits package|
|Contact name:||Katie Dunbar|
|Published:||about 1 month ago|
|Expiry date:||31 August 2021|
I am working with an international biotech at a hugely exciting phase of their growth journey, as they add Cell&Gene therapy products to their portfolio.
The Operational Quality Senior Manager role, based in Paris, will work with the Responsible Pharmacist to integrate the French Exploitant and medical charter requirements into the global Quality Management System. The role will act as deputy Responsible Pharmacist and assume overall QA responsibilities for activities associated with the French affiliate.
Additionally, the role supports commercial activities related to GDP, GMP, and geographic expansion. The post holder will act as a QP to release clinical and commercial products as needed, reporting into an Associate Director of Operational Quality.
Complete duties required as deputy Responsible Pharmacist.
Work with the International Operational QA team to ensure the requirements of the French Exploitant’s guidelines and Medical Charter are fully integrated into the global QMS. This will include:
Document Control, including SOPs, WIs, Site Master Files and forms
Complaints, Returns, Falsified Medicines and Recalls
Promotional Material and Healthcare Professional communications oversight.
Serve as Process Owner, for the French operations, and ensure appropriate execution of the following processes: Change Control; Training; GXP Documentation; Management review, Recall
Define and optimize work processes and serve as Document Owner and SME
Ensure processes are current and meet requirements of applicable regulations
Identify and analyse process-related metrics- monitor process-related metrics for efficiency and cost of quality
Serve as Training Owner and SME for processes. Responsibilities related to training will include:
Coordinating Annual GxP training for French staff
Management of “one-off” training events, e.g. internal/external training courses attended by French affiliate staff, ensuring appropriately captured, including training materials
Work with the RP to ensure annual training plans are in place for relevant French Affiliate staff
Coordinate the local French Management Review
Identify risks/communicate gaps to quality system owners/International Management Review/QLTs
Provide strategic direction for electronic system setup and configuration
Participate in Business Development Activities as needed
Input into the International Quality Management review process: Review global and international procedures
Responsible for Inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required. SME of all systems during the inspection and lead or co-lead the inspection.
Participate in Geographic Expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Wholesale Dealers Authorisation (or equivalent) application, audits and Quality Agreements.
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 cell and gene therapy products and ensure compliance
Master’s degree or BSc degree and strong relevant work experience
Able to act as a responsible pharmacist or a deputy responsible pharmacist named on the French Exploitant license and previous experience acting as a Responsible Person on an EU Wholesale Dealers Authorisation
Able to act as a Qualified Person in line with the requirements of directive 2001/83/EC.
Able to travel up to 20% of the time
Knowledge and experience of Cell & Gene therapies
Knowledge of GDP, GMP and GVP, with previous GDP auditing experience, GMP experience preferable
Ability to collaborate cross functionally across all levels of the organization
Ability to design, develop and deliver effective training
Ability to drive results
Analytical thinking / Data Analysis/ Attention to detail
Change Management and continuous Process improvement
Project Management- time and resource management and prioritization, planning and organization skills
Risk-based strategic critical thinking
This position is based in the Paris office, but will enable home working for half of the week. A generous salary and benefits package is on offer, and as a stable company with a fantastic pipeline, the opportunities for ongoing professional growth are huge.
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: €70,000 - €82,000 Per annum + Great benefits package
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