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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 Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

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 Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

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

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Engineering

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+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
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1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650