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GCP Quality Assurance Manager

Actelion Pharmaceuticals Ltd

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GCP Quality Assurance Manager

GCP Quality Assurance Manager - (1700006F)

Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Senior GCP
Quality Assurance Manager.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without
disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of
everyone in it.Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH
treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and
intravenous medications. Job Responsibilities

- Plan, prepare, perform report and present various GCP-related external and internal audits according to a
pre-defined audit plan (examples of audits: Clinical investigator site audits, vendor assessments/audits, internal
study/process audits, mock inspections)
- Ensure that Actelion clinical and regulatory quality documents are defined, created, maintained and implemented
globally in strict accordance with applicable regulations, Good Clinical Practice (GCP) guidelines and Actelion
- Report outcome of audits through detailed audit reports; Perform training based upon findings and working closely
with Clinical Trial Teams
- Act as subject matter expert in GCP guidelines, regulations and compliance-related issues; Advise clinical
development personnel according to needs/request and proactively determine the adequacy of on-going programs and
potential areas for improvement
- Oversee and drive change initiatives; evaluate interdepartmental business processes for improvement opportunities
and propose solutions
- Support Global Quality Management and R&D partners with hosting and/or facilitating regulatory agency inspections;
Ensure adequate follow-up on inspection findings until resolution
- Provide guidance and/or training to Clinical Trial Team personnel, third party vendors and investigators on GCP and
SOP/QA-related matters as appropriate

Candidate Requirements

- Bachelor's degree level, preferably in a scientific discipline
- At least 6 years in the pharmaceutical industry with 3+ years of experience in GCP Auditing (as a lead auditor)
- Possesses current, sound knowledge of the regulatory requirements and international guidelines governing the conduct
of international clinical studies
- Ability to prioritize work, manage multiple complex projects while maintaining quality
- Experience in international cross-cultural relations
- Strong writing, verbal and listening skills with ability to perform presentations to corporate and external audiences
- Able to work independently
- Ability to solicit and gain the support of others through effective negotiations and collaborations
- Reliable and conscientious
- Accustomed to working in a flexible teamwork environment
- Ability to travel at least 20% of the time

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your

Primary Location

: CH-BL-Allschwil


: Quality


: Full-time

Job Type

: Standard

Job Posting

: Jan 30, 2018