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Quality Director


Strategic, international quality management position
(Noord-Holland, Netherlands)

Het bedrijf / The company

Our global client manufactures and markets high-quality drugs in a diversity of fields. With a diverse portfolio of products and solutions, they are continuously providing patient healthcare solutions. They have built a promising pipeline centered around their core therapeutic areas. Through continuous investment in their research and development, marketing and business development, they keep growing their medicines business. Innovation is at the core of this company, with the aim of improving health and contributing to better, healthier lives. We are currently looking for a Quality Director to complete their European Quality Team.

Extra info

An individual assessment may be part of the selection procedure.

Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

De functie / The role

As Quality Director, you are responsible for the overall direction, coordination, implementation and execution of all Quality activities in 8 countries, in alignment with business units in order to ensure products are efficiently disitributed into the countries by meeting their regional and local standards and customer needs. In this position, you will support the relevant countries to roll out locally their Quality System. You ensure that all relevant local country suppliers/service providers are under control (including but not limited to: QTAs, Audit Program, PQR). You follow and trend-analyze monthly quality metrics in the countries and identify corresponding action plans. Furthermore, you are responsible for business support by participating in the periodic management meeting organized with other supportive functions (Supply Chain, Regulatory Affairs, Pharmacovigilance). When it comes to Critical Quality Incidents, you escalate to the regional quality issues raised at local level and support local quality departments to elaborate and deploy action plans related to quality incidents raised locally or regionally.
As Quality Director, you are also responsible for managing and leading the 8 Quality departments, and you train and provide professional guidance to teams. You define annual objectives in compliance with annual regional quality objectives. This position has 8 direct reports and a total of ca. 20 reports. You will report to the Sr. Director Quality Europe.

Het profiel / Your profile

o M.Sc. degree in Pharmacy, Biology, Healthcare or equivalent is required; post-graduate or doctoral degree is preferred
o minimum of 7 years of experience in a Quality Role in the pharmaceutical field, and a minimum of 7 years of experience as a functional leader within an international environment
o experience or history of being a Qualified Person is required
o in-depth knowledge of the pharmaceutical industry as it relates to Quality Compliance
o in-depth understanding of GMP & GDP regulations
o experience with development and implementation of Quality Systems and application of risk assessment tools
o strong problem solving skills, autonomous and independent, strong collaboration skills, and management and leadership skills. Able to inspire and motivate a team.
o excellent communicative skills in English, Dutch is preferred.

Het aanbod / The offer

o strategic management position
o responsible for 8 countries
o working for a company with a diverse and interesting product portfolio
o attractive remuneration package

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-043-FMF, to Sophie van Baalen : info@derksenderks.nl.
For further information, please call Sophie van Baalen or Vera Hudepohl at number +31 (0)33 472 80 87.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.



Derks & Derks B.V.

Geplaatst op FMF: 29 april 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 5-10 jaar, > 10 jaar