International Senior Quality Manager - Qualified Person

My client have an essential requirement for a QP/RP role to ensure holding of Manufacturers Import Authorisation and a Wholesale Dealers Authorisation in the EU. This role will be responsible for ensuring the quality system is in place and meets the requirements of GMP and GDP. Currently holding a WDA, this role would help establish an appropriate QMS and apply for a MIA. This role is also responsible for ensuring compliance and full oversight of regulations and procedures for existing commercial products and for clinical development, cGMP manufacturing and testing of commercial cell and gene therapy programs.

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Key Responsibilities:

• Maintain and enhance the QMS to ensure all requirements are in place to apply for an MIA

• Ensure WDA/MIA accurately reflect the current organisation, varying where necessary

• Enhance the QMS to support the QP certification of cell and gene medicines.

• Planning/ Preparation/supporting/hosting for Regulatory inspections

• Providing front and backroom inspection support

• Post inspection follow-up with responses and CAPAs (Continuous improvements)

• Manage/Approve/Assess event investigations “deviations”

• Manage CAPAs and Effectiveness Checks

• Monitor, assess impact and communicate Regulatory Intelligence information

• Perform QP duties as per the GMP guidelines

• 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 cell therapy, gene therapy etc.

• Perform RP duties as per GDP guidelines

• Create/review and approve SOPs and other Quality Documents

• Support product recalls for Ireland and Review Product Returns from Irish Market

• Support International QA in the maintenance of the international QMS

• Build strong working relationships with International Supply Chain, Regulatory, Technical Operations and the global quality functions.

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Key Requirements:

• Master’s degree with strong relevant work experience, or Bachelor’s degree and extensive relevant work experience

• Eligible to act as a Qualified Person in the European Union

• Eligible to act as an Responsible Person in the European Union

• Good understanding of cell and gene therapy quality area – manufacturing or testing

• Experience working in an internal bio-pharmaceutical development/production environment

• Experience of working in an international organisation, with international affiliates and within a matrix environment

• Extensive experience of GDP and GMP

• The ability to lead regulatory inspections

• Ability to learn new information and roll out to the wider audience

• Work cross functionally with all levels to foster exceptional collaboration and drive breakthrough results

• 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 required for the role.

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My client are a highly respected biopharma business, and offer great career progression, a generous benefits package and an exciting work environment. 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.

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Salary: Highly competitive + Benefits - Depending on experience