Director Clinical Compliance QC

Hobson Prior are looking for a Director Clinical Compliance QC who will join a top biotechnology organisation in Hertfordshire. You will lead the development of integrated process and oversight of compliance to legal, regulatory and industry standards within the Clinical Development function, incorporating Clinical Operations, Medical Science, Biometrics, Pharmacovigilance and Medical Affairs.

Job Responsibilities:

• Establish a process improvement culture and embed QC standards in a proactive and on an ongoing basis.
• Regularly perform gap analysis assessments for processes and procedures within the group. Ensure that the identified gaps are addressed through process improvement.
• Develop and assess SOPs, Working Practices and Forms that are easily followed in order to ensure they adequately reflect best practices and comply with regulatory guidelines
• Develop a methodology for monitoring compliance to procedural documents by internal staff and external Sites and partners.
• Build a comprehensive set of metrics to monitor the effectiveness of the core clinical processes on an ongoing basis.
• Maintain awareness of regulatory standards.
• Comprehensively assesses team training needs and deliver internal training as required.
• Contribute to vendor assessment and outsourcing strategy at study and portfolio level for GCP deliverables.
• If applicable provide line management oversight to members of staff.
• Work with Quality Assurance to support audits of internal process & external suppliers and regulatory inspections as required.

Key Skills:

• Excellent technical writing and verbal communication skills.
• Ability to operate in a matrix and team oriented working environment.
• Competent with computer software (word, PowerPoint, excel, outlook).
• Excellent communication skills and ability to work with people in all levels of the organization.

Requirements:

• Bachelors or Master's degree with at least 10 years of relevant industry experience.
• Extensive experience and knowledge in the development of procedural documents.
• Demonstrated knowledge of clinical/medical processes including GCP, GDPR, GPvP.
• Skilled in Process Improvement Methodology.
• Demonstrated experience leading process improvement initiatives.
• Demonstrated skills in taking initiative and working independently.
• Experience with line management, hiring and personnel development.
• Experience with vendor oversight practices.

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.