WE TAKE  THE
FRESH APPROACH

by nature

Home > Talents

Head of Regulatory Affairs and Quality Assurance Benelux

Introduction


Head of Regulatory Affairs and Quality Assurance Benelux


Company/Department


Quality and Regulatory Affairs department


Function information


Lead and manage a pool of talented people on a daily basis; to improve the overall working of the QA/RA department.

REGULATORY AFFAIRS & QUALITY ASSURANCE

Being a crucial link between the company, its products and the regulatory authorities, you ensure that the company adheres to internal and external regulations. Combining legal, technical, business and regulatory experience, you advise and support the company in their product development, marketing and after sales support;

·        Overall responsibility for the Quality Assurance in the group;

·         Implement cost effective QA operations to ensure a lean and agile structure;

·         Assist in building and maintenance of QA systems with a mission to simplify where possible.

PHARMACOVIGILANCE
 Fulfillment of PV legislation;

·         Responsible for the safety activities;

·         Responsible for the medical review together with PV colleague.


SCIENTIFIC SUPPORT

Responsible for developing and facilitating the relationship with the medical/scientific community, internal partners and patients, by communicating product-related information;

·        Work together with the RIP, Sales and Marketing colleagues;

Responsible for contents of training for internal staff.


Requirements


Qualification requirements

Qualified Person status is preferred;

·         Preferably pharmacy/chemistry graduate;

·         Minimum 10 years’ experience in the pharmaceutical industry, (include significant experience in GMP and GDP, in roles of a related discipline e.g. Quality Assurance, Operations) and RA;

·         Minimum 5 years’ experience at senior management level;

·         Languages: very good Dutch, French and English (written and oral).

 

Abilities

  Proven leadership and organizational skills;

Proven ability to manage complex quality and RA issues and deliver solutions to champion business growth;

Proven ability to work in multidisciplinary teams and ability to balance the requirements of GMP with the business reality;

Ability to contribute proactively to a continuous learning and process improvement environment;

 Good capacity to adapt and cope with shifting priorities; a can-do attitude;

 Self-starter, motivated, takes initiatives. A passion for cultivating strong internal/external client relationships;

Maintain a pragmatic approach to problem solving, within the discipline of a business environment.



Offer


open-ended contract + interesting extralegal advantages


Information


Sandra Rizzuto

sandra.rizzuto@xpe-group.com


Interested in this job?

APPLY NOW

Not what you're looking for?


Spontaneous application

Haven't found the dream job you're looking for? Submit a spontaneous application now!

Spontaneous application
*}