Vice President, Global Quality Assurance

Job Description

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so, each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Place in the Organization

Reporting to the Chief Technical Operation Officer, the VP of Global Quality Assurance Officer provides strategic quality leadership along the entire value chain of product development and commercialization with a strong compliance emphasis on GxP (GLP, GCP, GVP and GMP). The role provides leadership and collaborates with all functional areas to ensure compliance with applicable GxP regulations to support uniQure’s corporate strategy.

The VP of Global Quality Assurance is responsible for ensuring that all internal and external audits (investigator, GLP/GCP/GVP (e.g. CROs)/Pharmacovigilance (PV)/bio-analytical vendors and facilities and systems) are conducted, results are communicated, and appropriate corrective actions are implemented. This position will lead the preparation, execution, and responses to regulatory agencies (e.g. FDA, EMA) inspections. To that end, the candidate will work with internal and external stakeholders to prepare for inspection readiness efforts in support of the company's product commercialization efforts.

Key Result Areas (Major Duties, Accountabilities and Responsibilities)

• Responsible for developing, and implementing the global Strategic Quality Plan.
• Responsible for setting Quality requirements for corporate objectives and for providing strategic leadership supporting these requirements.
• Ensure company-wide compliance with applicable Regulations.
• Ensure a strategic audit plan is designed and implemented for all uniQure's functions, processes/systems, vendors, and products.
• Ensure the Quality organization has systems and processes to support commercial product disposition.
• Collaborate with Safety, Supply Chain and other functions to create a Technical Product Complaint organization to support product commercialization.
• Directs the Quality oversight of GxP and bio-analytical activities (including internal or external audit observations and development of adverse trends) to ensure patient safety and data integrity.
• Supports Quality activities during due-diligence and business development efforts.
• Partner with Regulatory on the development and submission of regulatory dossiers globally and submissions to regulatory authorities.
• Accountable for regulatory inspections and compliance audits.
• Develop budgets for relevant functional responsibilities.
• Foster and develop a productive organization of talented employees, including the management, motivation, recruitment and evaluation of personnel.
• Responsible for definition, implementation, maintenance and continued improvement of processes and systems, supported by meaningful Key Performance Indicators (KPI’s).
• Interact with staff of other disciplines, such as Commercial, Finance, Research & Product Development, Human Resources, Legal, Business Development, Investor Relations and Clinical Development to ensure efficient day-to-day cooperation and success for the business.

Qualifications & Skills

• PhD or MSc in life sciences or equivalent experience.
• A minimum of 15 years working in the pharma/biotech or related sector in a Quality role with 10+ years minimum in a leadership role directing a Quality Unit.
• Industry experience in biologic products is required.
• Expert knowledge of US and EU and ICH GxP guidelines.
• A strong scientific background within the field of biosciences and gene therapy and/or live viral vaccine experience is desirable.
• Experience in leading and hosting regulatory inspections and interactions (at minimum FDA and preferably EMA as well).
• Proven experience with new site development, commissioning, qualification, and validation.
• Understands phases, and processes used to execute pre-clinical and clinical studies.

Core Competencies

• Ability to analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling; to create realistic goals and implementation plans that are achievable and successful.
• The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.
• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
• A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions.
• The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance.
• The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.
• A leader who is self-reflective and aware of their own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement.
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.