Qualified Person or Responsible Person as Operational Quality Senior Manager

Location Paris, Paris, Île-de-France Region
Discipline: Quality Assurance, Regulatory Affairs
Job type: Permanent
Salary: £Salary: €70,000 - €82,000 Per annum + Great benefits package
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21727
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.

Key Responsibilities:

  • 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:

    • Change Control

    • Deviation Management

    • Document Control, including SOPs, WIs, Site Master Files and forms

    • Risk Management

    • Management Review

    • Self-Inspection/Internal Audit

    • Vendor Management

    • Customer Qualification

    • Complaints, Returns, Falsified Medicines and Recalls

    • Regulatory Intelligence

    • 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

Key requirements:

  • 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

  • Adaptability /Flexibility

  • 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

  • Technical writing

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