Associate Quality Assurance Manager

OMQ-P2-11

Associate Quality Assurance Manager

Location: Paris, France

Department: Quality Assurance

Job type: Permanent

Join us and make a difference when it matters most! 

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. 

The Team

The Associate Quality Assurance Manager role will join the Quality Assurance team in Paris and will support the FR-BeNeLux Quality Pocket Lead. The role will act as marketing authorization holder (MAH) in accordance with applicable GDP and linked regulations for Mundipharma Products (example: PQR, ...) and conduct any other pharmaceutical tasks required (advertising, pharmacovigilance etc). 

The Associate Quality Assurance Manager must hold a Pharmacy Degree and will look to be trained in a Deputy Pharmacist role.

Role and Responsibilities

• Ensuring that all the activities performed are maintained in compliance with applicable regulations, that appropriate authorizations/licenses and certificates are in place and current and that the integrity and safety of product are maintained throughout distribution via an effective Quality Management System.

• Regional legislation change review. Responsible for implementing relevant changes on a local level when regional/global legislation changes.

• Quality metrics reporting in accordance with the global reporting system of the company.

• Reporting and escalation of urgent quality issues to the FR-BeNeLux Quality Pocket Lead and the Responsible Pharmacist.

• Responsible for conducting Quality impact assessment on global/central changes affecting the company (MAH) and ensuring creation and completion of necessary action items. Responsible for ensuring risk assessment principles are applied.

• Ensure an effective Quality Management System being established/implemented, maintained and operated in line with current GxP requirements, local regulatory standards, and Mundipharma standards for all relevant product classes on the global electronic platforms used in the company.

• Maintenance and operation of local GxP change controls, deviations and CAPAs on the global electronic platforms used in the company. 

• Appropriate receiving and handling of complaints, (suspected) product defects and (suspected) falsified medicinal products, security incidents, product recalls, adverse drug reactions and other safety information, and reporting to the Responsible Pharmacist.

• Periodic evaluation of the effectiveness of the arrangements in place for product recalls.

• Monitoring of quality system (including trending) and continuous improvement via Product Quality Reviews (PQRs), audits and self-inspections, Quality metrics and Quality Management Reviews.

• Ensuring the necessary qualifications and technical agreements / delegation letters etc. are in place for 3rd party GxP services provided and products supplied to the local company.

• Ensure recommended product shortage prevention and management plans in place. 

What you’ll bring

• University degree in Pharmacy

• Master's Degree in Quality Assurance or Regulatory Affairs or other Pharmaceutical Affairs would be Ideal 

• Ability to work collaboratively maintaining good working relationships with cross functional teams and partners actively participating contributing to team success

• Fluent in spoken and written English. Other languages appreciated (Dutch).

• Proficient in the use of Microsoft Office applications.

• Competent in use of databases (preferred)

• Proactive, pragmatic, independent, organized and self-confident.

• Customer focused and cross-functional thinking and behavior

What we offer in return

• Flexible benefits package

• Opportunities for learning & development through our varied programme 

• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect. 

About Mundipharma

Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.  

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.  

Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.

Additional Job Description:

Primary Location:

FR Paris

Job Posting Date:

2025-04-03

Job Type:

Permanent