|Discipline:||Quality Assurance, Regulatory Affairs|
|Salary:||£Salary: Highly Competitive + Benefits Package|
|Contact name:||Katie Dunbar|
|Published:||about 1 month ago|
|Expiry date:||19 June 2021|
A leading biopharma business is looking to make a critical hire, of a Senior Director who will take responsibility for GDP Operational Quality Assurance, supporting international expansion worldwide.
This role will establish processes and capabilities for effective, proactive, quality risk management across all product areas, taking overall responsibility for:
Establishing appropriate global and local QMS
The hiring of appropriate Qualified/Responsible Persons/QA in local countries/affiliates
Assuring real-time inspection readiness.
Provision of strategic oversight and leadership for Quality Management Reviews
Ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies/controls proactive and sustainable compliance.
Integration of end-to-end quality principles and review preparedness at key milestones
Essential Skills and Competencies:
Master’s Degree in relevant scientific discipline and extensive relevant work experience
Ideally Qualified Person as well as extensive RP experience.
Broad global regulatory agency knowledge and experience across multiple GDP/GMP/PV with knowledge of current industry trends and best practices for efficiency, compliance, and effectiveness.
General knowledge in electronic system compliance and GCP/GLP requirements
Proven ability to design, evolve and implement quality strategies, enabling effectiveness and adaptability in a dynamic business model
Demonstrated success in establishing affiliate business units and build-out of international quality organizations, ensuring operational excellence.
Strong problem solving, analytical, and critical thinking skills; makes sound decisions
Operational Excellence experience such as Root Cause Analysis, LEAN, DMAIC, Six Sigma, risk-based quality principles (e.g., QbD), applied in a pharmaceutical environment
Leadership and change management experience, able to develop individuals and teams, with excellent communication skills and a proven track record promoting a culture of Quality and Excellence
Experience in Gene and Cell therapy manufacturing and distribution will be highly advantageous
A competitive package is on offer, commensurate with the experience required of the ideal candidate. Flexible working is available but weekly work in the London office and travel will be required.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.
Salary: Highly Competitive + Benefits Package
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