Senior Clinical Quality Assurance Manager USA

Location: 

Radnor- Philadelphia Area, PA, US

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub and with US Corporate offices in both Radnor, PA and Cherry Hill, NJ, Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a Senior Clinical Quality Assurance Manager USA to join our team.

 

Job Responsibilities

 

•    Work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process)
•    Plan, perform, and report audits in USA and internationally (e.g. Europe, Asia, South America for site, vendor, process) using considerable latitude in determining best practice and approach
•    Develop own area of US regulation and ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself)  
•    Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities 
•    Facilitate the CAPAs elaboration and follow-up
•    Escalate serious / continuing non-compliance issues as appropriate
•    Make a significant contribution to ensure that QS documents creation and management is done in accordance with US regulation and ICH-GCP requirements / regulations 
•    Contribute to process improvements and trouble shooting
•    Maintain awareness / expertise in US regulation and international ICH-GCP requirements 
•    Provide leadership and direction on US regulation and ICH-GCP related activities / issues
•    Work closely with Idorsia / CRO Clinical Trial Teams 
•    Support Idorsia / CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to US regulation and ICH-GCP questions)
•    Highly contribute to develop/improve CQA tools and processes 
•    Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available 
•    Perform any other CQA task that could help to achieve a high adherence to US regulation and ICH-GCP requirements 

 

Candidate’s Requirements

 

•    Bachelor’s degree or equivalent education/degree in (life) sciences or healthcare
•    Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience in Quality Assurance / Auditing (QA) within US regulation and the ICH-GCP environment.
•    In-depth knowledge of US regulation and global ICH-GCP requirements and pharmaceutical industry practices
•    Ability to work as a team player and independently 
•    Reliable, conscientious, agile/flexible
•    Proven record of excellent problem solving, risk analysis and negotiation skills
•    Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource)
•    Experience in medical device and/or combination product will be an added value 
•    Strong writing, communication and listening skills
•    Experience in international cross-cultural relations
•    Strong English language skills (written and spoken)
•    Ability and willingness to travel in USA and internationally (e.g. Europe, Asia, South America) at least 25% of the time


What Idorsia offers

 

•    Exciting opportunities for development and professional growth within our dynamic organization
•    A collaborative and solution-oriented environment where you can make a difference
•    An innovative and open culture in a truly multicultural environment
•    A competitive salary and generous social benefits

 

Work Location: Radnor, PA, US

Country: United States of America

Business Area: Quality Assurance

Schedule: Fulltime

Job Type: Permanent

Job Code: 2207

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


Nearest Major Market: Philadelphia