Head of Research & Development Quality

€0.00 - €150000.00 per annum
  1. Permanent
  2. Senior/Director & VP, Good Pharmacovigilance Practice (GVP)
  3. Iceland
Posting date: 21 Feb 2019

ProClinical is excited to be partnered with a leading Biotechnology company that focus on developing high-quality Biosimilars for the appointment of a Head of Research and Development (R&D) Quality. This company has already received more than half a $Bn in funding; has built a state-of-the-art R&D and manufacturing facility and has 7 assets currently in the pipeline.

As Head of R&D Quality you will be responsible for strategic and operational management of the Quality activities for the development of new biosimilar products, from Early Stage Development to Development DS and DP teams across 4 sites in Europe. This role bears the primary responsibility for development QA oversight.

Job Responsibilities:

  • Overseeing, assessing, and working directly to continuously improve development quality processes and supporting the state of Quality Compliance.
  • Partnering with business stakeholders to ensure the alignment, coordination, and delivery of research quality strategy & goals for the non-GxP regulated area.
  • Creating, developing, and maintaining an effective Development Quality system.
  • Training and mentoring staff on global development Quality regulations and guides.
  • Driving the evaluation of existing development processes across the organisation to identify risks and potential gaps to the company and regulatory requirements.
  • Liaising with stakeholders to prioritise, develop, and implement plans to address gaps and ensure sustained compliance.
  • Serving as SME in the development quality area and acting as a primary contact for internal and external stakeholders.
  • Fostering a quality culture and mindset with all business process owners.
  • Establishing and maintaining processes to formally track compliance with established research quality standards and monitoring effectiveness relative to established objectives.

Skills and Requirements:

A scientific background and university degree (PhD preferred, MSc also considered) in a Life Science field.

Significant experience within the Biotechnology/Biopharmaceutical sector.

Demonstrable experience working within GxP quality area, with specific experience working in non-GxP quality areas a significant advantage.

Excellent knowledge of R&D quality processes and procedures.

Capable of liaising with stakeholders across all levels of the organisation along with demonstrated success in a 'matrix' type role is required.

An ability to learn, assimilate, and effectively communicate information to support colleagues, discuss with partners, and advise clients of regulatory requirements.

Strong interpersonal skills, including communication, leadership, relationship management, and influencing.

Capable of leading interdisciplinary projects and to implement change within a high-performing organisation.

Demonstrable computer software skills, including MS Office, Oracle, and Concur.

A flexible mindset that is suited to dealing with multiple projects in a timely manner.

In Return:

You will get the chance to work for a company that are set to be the world's leading producer of high-quality Biosimilars and oversee Quality strategy as they continue to grow and commercialise their pipeline. There is an excellent remuneration package on offer that will include international relocation support for you and your family if necessary.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Josh Godden on +442038540101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.