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Compliance Director

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The company

Our client is a professional organisation, based in Noord-Holland Netherlands. .

Role description

You will need to interface with all site functions and the global Quality organization and you will be responsible for oversight and activities related to the management of regulatory inspections, the site auditing program, significant investigations and recall execution, CAPA management, regulatory compliance, complaints management, site quality agreements and data integrity compliance.

Responsibilities

Lead the site wide Permanent Inspection Readiness (PIR) program, influencing all IPT's (Integrated Process Team) and CoE's (Centre of Excellence) at the site. Report to Site Leadership Team on necessary GMP improvement programs for the site to remain permanent inspection ready.
Make independent decisions on the implementation of the quality management system (QMS) at the site.
Managing the quality function including interacting/developing relationships with regulatory agencies in the Netherlands as well as EMA and the FDA.

Requirements

Master's Degree in Pharmacy, Life Sciences, Engineering
A minimum of 8 eight years' experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site in quality and/or manufacturing roles.
Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirement
Demonstrated leadership and change management skills with focus on continuous improvement
Registration as Qualified Person is preferred

Other information



Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.

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SIRE Life Sciences®

Ref. number: 47202
Listed by: SIRE Life Sciences®
Listed on: 27-03-2019
Country: The Netherlands
Region: Noord-Holland
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277