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Reporting to: Chief Technical Officer
Location: Europe or US
Job Summary
Reporting to the Chief Technical Officer, the VP Global Quality will be a key member of the Technical Operations Leadership team, responsible for the conpany’s Quality, providing strong leadership that ensures implementation of and compliance with global quality standards at all levels, supporting research, clinical development and manufacturing through to and beyond product registration.
He/she will ensure that the company achieves the expected quality standards for GMP, GCP, and GVP documents and database mantainance as well as infrastructure, facilities, training records, including those of the partner teams/academic institutions working with the company.
The position is global, and will cover all activities in all key territories in support of the company strategy and so the incumbant will need to partner with CDMO’s, counterparts from academic centres, partner companies and other groups, as required.
It is expected she/he will work closely with all R&D functional areas, including manufacturing, medical affairs and regulatory, both internally and with third parties (CDMOs, CROs, etc.).
Responsibilities
Develop long-term Quality strategies, providing leadership in policy setting, operational support, driving a work culture fostering a highly ethical environment grounded in credibility and trust and fully committed to patient safety, compliance, quality and excellence in a changing environment. This includes developing and driving implementation of the quality management system, staffing, and associated processes thereby ensuring adequate checks and balances exist and establishing the appropriate independence of the quality function, and expeditious patient access to high quality, well-differentiated products.
Lead the Quality organisation including development and maintenance of phase appropriate quality management systems (QMS) ensuring compliance with GxP and global regulations, forging collaborations with extensive network of vendors and internal stakeholders.
- Provide inspirational leadership to the Quality team, ensuring that they are aligned with organisational objectives and have the skills and competencies to deliver on the needs of the business and support the development of the produce pipeline
- Ensure effective and efficient organization of the team, provide adequate resources and actively participate in management reviews to ensure the quality system is suitable and effective to satisfy regulatory requirements and the company's Quality policy and objectives across GxP functional areas
- Partner with leadership in Technical Operations, Clinical Development, Regulatory and other functions to ensure organisational compliance
- Develop and implement continued improvements in Quality Systems to reduce complexity; improve effectiveness, efficiencies and productivity, supporting sustainability and harmonization
- Develop and implement systems to monitor compliance and consistency to Out of Specification (OOS), Investigations, Deviations and CAPAs throughout vendor network , improve management of customer complaints process
- Effectively communicate progress and issue resolution to appropriate internal/external stakeholders and through Quality Management Review
- Oversee the integration of GMP principles to R&D activities, the timely release of clinical and commercial supplies and the execution of internal and external audit plans
- Establish risk-based quality plans and provide oversight and guidance on current GxP regulations & guidelines, provide risk-based advice to enable decision making and support the development & execution of effective CAPAs as needed
- Provide leadership and strategic direction for the Quality Management System (QMS)
- Ensure a robust and risk-based Audit program is successfully realized throughout vendor network
- Ensure regulatory compliant Quality Management practices and procedures at external manufacturing, testing and clinical sites through the audit function are met
- Ensure organisational readiness for external inspections by any regulatory authority
- Evaluate and provide risk assessments to senior leadership on critical R&D activities on an as needed basis, including before, during and after inspections
- Provide ongoing education and training to support the effectiveness of the company compliance programs
- Implement company SOPs that ensure compliance.
- Lead the Data & Documentation Reviewers, of overall company Data & Documentation/QA
- Develop and ensure achievement of overall Quality budget and supporting the corporate and departmental goals
Requirements
Experience
- Managerial experience in a senior leadership role with substantial experience in leading all quality and regulatory aspects of a program
- Understanding and experience of applying quality processes within the manufacturing and clinical research environments, GCP/ICH and GMP
- Experience in regulatory CMC, quality for filing/approving and launching in at least US and EU territories
- Have at least develop or participated in one submission, preferably worldwide
- Understanding of new trends in developing orphan/rare/ultra-rare diseases
- Experience managing complex GT programmes from regulatory/quality stand point
- Experience training people and academic centres
- Experience with FDA/EMA and ideally other regulatory groups
- Several years of industrial experience at biotechnology, medical or biopharmaceutical companies
Skills
- Collaborative working syle; the ideal candidate will partner effectively with her/his colleagues across the organisation to seek critical information, constructively challenge plans and assist with the optimal allocation of resource
- Strategic mindest/creativity/pragmatic/flexible/ethusiast/can-do attitude
- Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contibute to several projects in parallel
- Adaptable to a fast moving changing environment
- Several years leading large teams of people with indirect and direct reports, in a global environment in a matrix organisation
- On a personal level the candidate must be a highly articulate, authentic and fluid communicator in both inidual and group settings. This position requires heightened intelligence, mature business judgement and a passion for developing completely novel therapeutics.
- The candidate should be able to gain credibility within the organisation as well as with scientific founders, partners and investors.
- The candidate should be capable of operating with a high level of autonomy in a semi-virtual environment, creating the strategic vision, but getting into the detail as required.
Education
- Life science academic background, educated to at least degree level, ideally with a post-graduate qualification
