Quality Programme Team Representative

Hobson Prior are currently working with a specialty biopharma organisation who are focused on the advancing and manufacturing biosimilar medicines. Our client is looking for a Quality Programme Team Representative to join them on a permanent basis in either Iceland, Germany or Hannover/Julich.

Job Responsibilities:

• Working as a Quality program team representative participating in the organisations program teams.
• Partner as product key expert with different department, e.g. regulatory affairs, clinical operations, manufacturing, and within Quality division to enable informed decision related to e.g. deviation management, change management etc.
• Direct efficient expert network within Quality departments and business functions by sharing product expert knowledge for products and sharing key knowledge for business decisions.
• Direct and monitor Corrective and Preventive Actions resulting from e.g. deviation management, change management between the organisations global sites for respective products.
• Monitor Quality along supply chain for respective products (internally/externally).
• Set definitions of appropriate product quality standards that ensure compliance of products with applicable regulatory standards and customer expectations.
• Ensure compliance by monitoring e.g. product quality reviews for respective products.

Key Skills:

• Business process management and stakeholder management skills.
• Demonstrated ability to communicate effectively with people at all levels in the organization and divisions, as well as regulatory agencies.
• Demonstrated ability to navigate matrix organizations and support multiple business processes.
• Excellent written and oral communication skills in English.
• Critical thinking and evaluation of process problems.

Requirements:

• Master of Science in life sciences; pharmacy, biotechnology, biochemistry, chemistry or related fields.
• A minimum of 15 years' experience in biotech Quality, Regulatory and/or Operations.
• Quality assurance experience and knowledge of biotechnology processing and testing.
• Demonstrated experience leading cross-functional teams and influencing through indirect leadership, to build collaboration and drive resolution.
• In-depth knowledge of pharmaceutical analytical technologies, including drug substance manufacturing of monoclonal antibodies, sterile manufacturing, secondary packaging, medical device operations and distribution including all governmental and agency regulations.
• Broad current Good Manufacturing Practices (cGMP) experience and knowledge, QA/QC and regulatory compliance (US and other international agencies).

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 focused 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.