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Manager Clinical QA

priority vacature priority vacature



A temporary assignment (12 months) at a large pharmaceutical company

Het bedrijf / The company

Our client is an international, pharmaceutical company. The company"s activities comprise the development, production and sales of medicines. For the facility in Leiden we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented manager Clinical QA.

De functie / The role

As a Manager CQA you are responsible for the management of multiple regional, cross regional and/or global audit programs. This includes the independently scheduling, scoping definition, planning, conducting and reporting of audits, liaising with stakeholders on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for the continuous improvement of the organization. You manage and follow up on findings and improvement areas. Also you may represent CQA as a Global Quality Lead for M&D projects across Therapeutic Areas. You provide support and consultation to other CRQA functional areas as needed. Also you are responsible for providing unsupervised GCP expert advice to key personnel. This includes and is not limited to developing training materials and providing GCP training internally and externally. In case of regulatory agency inspections you do the review of responses from operations before sending it to CQA management for their final review and approval. You are responsible for regulatory inspection preparation across the region and globally. You will analyze the risks, define the strategy for inspection readiness and manage the roll out of the inspection readiness program across departments and territories ensuring a harmonized approach. You identify outsourcing needs, selecting, managing and evaluating 3rd party QA service providers of which audit and/or consultancy activities have been outsourced. You support the development, improvement and maintenance of the Quality System by identifying root causes to non-conformances related to the processes and/or systems, and by addressing observed gaps in these processes and systems. You manage quality issues related to critical nonconformances, suspicion of scientific misconduct and/or potential fraud. Furthermore you manage or support GCP inspections.

Het profiel / Your profile

o Bachelor degree
o minimum of 5 years in pharmaceutical, biotechnology, or related industry
o minimum of 2 years significant experience in Clinical Quality Assurance
o minimum of 2 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
o in-depth understanding of GCP requirements for both marketed and investigational products
o practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle
o effective oral and written communication and presentation skills in English
o proficiency in Microsoft Office
o domestic and international travel at 10-25% as required

Het aanbod / The offer

o a challenging job within a pharmaceutical company
o a temporary assignment till January 2020
o contract of Derks & Derks Secondment & Interim

Reactie / Reaction

Interested? Please send your resume and motivational letter by Email, with reference to DT/19-027-FMF, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten 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 Detachering
Derks & Derks
Leiden, The Netherlands

Geplaatst op FMF: 18 januari 2019

Branche: Farma & Biotech, Medical, Healthcare
Functie: QA / regulatory, Clinical research, Management
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 2-5 jaar, 5-10 jaar