VACANCIES

Quality Manager

  • Location: Central London, UK or Berlin, Germany, hybrid working model.

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Quality Manager

Clinical Services International is a specialized supplier of pharmaceutical products and services for clinical trials.

We offer a fully integrated service: Comparator Sourcing and Reference Listed Drugs Manage the entire supply chain and offer tailor-made solution for clinical trials Advancing Immuno-Oncology studies with world-leading access to Branded Medicines, Generics and Biosimilars. For further information please check our web site www.clinicalservices.eu

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Job Description:

The Quality Manager is responsible for the maintenance & co-ordination of compliance and quality monitoring and recording of relevant activities. Oversight of good compliance practices includes commercial and operational activities of the CSI team and our partners and ensuring that all business activities are conducted in accordance with relevant rules and regulations including all relevant codes of conduct and WDA. This person will take a leading role in the due diligence process, regular certification, training and monitoring of partners.

The Quality Manager supports all the activities related to the role; QA, processes governance, internal policies and procedures and healthcare compliance.

They ensure high quality standards to meet all applicable regulatory requirements, including EU Good Distribution Practices (2013/C 343/01) and other relevant regulations across the region. Working closely with the Management Team and with other key process owners he/she is responsible for advising on the potential risks of any activity in accordance with legislation, guidance, Codes or any company policies.

They act as the link between Quality and Business functions, taking care of and supporting the implementation and training responsibilities for Quality and Compliance SOPs.

The incumbent has responsibility for ensuring all activities are executed in accordance with regulatory and legal frameworks including but not limited to regional compliance legislation and guidelines, GxP regulations and CSI SOPs and compliance procedures.

Quality Manager - Oversight and support to GxP related affiliate activities:

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Key Skills & Experience required:

Required/Preferred Education and Licenses

  • Bachelor degree in scientific or allied health subject matter is preferred;
  • Minimum five years of QA/Compliance experience in a pharmaceutical or medical device company.
  • Permit to work in the UK or Germany necessary.

Experience in the following areas is a plus:

  • Knowledge and understanding of the healthcare compliance framework within the EU
  • Proven experience in identifying and resolving healthcare compliance issues quickly and effectively;
  • Demonstrated experience in prioritising conflicting demands in a fast-paced environment;
  • Independent thinking and action, as well as the potential to develop and take on increased responsibility;
  • Outstanding interpersonal skills and proven ability to communicate and work with all levels of the organization (including regional management and field personnel);
  • Excellent verbal and written communication skills in English. Fluency in another EU language is an advantage;

In return we offer:

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An amazing opportunity to contribute to a fast growing, pharmaceutical company and potentially move along our subsidiaries.

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A 'can do' culture where you will be encouraged to get involved in a range of exciting initiatives and to introduce new ideas, work directly with some of the largest Pharmaceuticalcompanies

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A warm, welcoming environment based in Central London

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The opportunity to learn new skills and ongoing personal development and career opportunities

Package:

Competitive salary dependent on experience, annual leave plus Bank Holiday, Pension Scheme, great working environment.

What’s in it for you?

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Career Progression: You will be able to develop your career with a wide variety of opportunities and work with highly experience people in the industry.

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From continuing your professional development in clinical services, to engaging with Blue Chip Pharmaceutical clients all over the world.

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Develop scientific knowledge and expertise in clinical trials and drug development.

Competitive salary dependent on experience, 25 days annual leave plus Bank Holiday, Pension Scheme, great working environment.

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