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Clinical QA Manager

Employer
Hobson Prior
Location
Zurich, Switzerland (CH)
Salary
CHF110,000 – CHF125,000 per annum
Start date
15 Mar 2019
Closing date
11 Apr 2019

View more

Discipline
Clinical Research, Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Hobson Prior is working with a Swiss clinical stage biopharmaceutical company focused on advancing modern medicine and improving the management of serious diseases. Our client is looking for a highly motivated Clinical QA Manager. The QA Manager will be responsible for quality assurance, with respect to clinical development activities in compliance with GCP, applicable regulatory requirements and corporate procedures.

Job Responsibilities:

  • Establish and review the quality/clinical documents and processes and whilst maintaining the archive for long-term storage of regulated documents.
  • Participate in the maintenance and continuous development of the Quality System.
  • Set-up, maintain and manage the CAPA system to ensure timely remediation of quality incidents identified at the company’s clinical sites and vendors, e.g. during monitoring, audits or inspections.
  • Give project team guidance on GCP, GCLP and applicable regulations (e.g. clinical operations, medical/safety, project leaders, bioanalytics, IT, etc.).
  • GXP compliance of computerized system validation/qualification and change control according to GAMP5 and 21CFR11.
  • Follow-up of non-compliance to the Quality System and applicable regulations in an effective way.
  • Maintaining a GCLP laboratory and support the implementation.
  • Identify trends and changes for areas of improvement within regulations, guidelines, and recommendations.

Key Skills:

  • Pragmatic problem-solving capabilities
  • Strong analytical skills and attention to detail
  • Team orientated, strong service delivery focus
  • Excellent verbal and written communication skills


Requirements:

  • Clinical quality function experience – minimum of 5 years
  • In depth knowledge of GCP, good understanding of the legal and regulatory framework around GXP
  • Involvement in running clinical trials in EU and US
  • Experience in performing audits
  • Life Science’s degree
  • Working knowledge of GCLP and GMP would be an advantage
  • Fluent in verbal and written German and English

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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