uniQure
Vice President, Global Quality Assurance
uniQure, Lexington, Massachusetts, United States, 02173
Overview
Vice President, Global Quality Assurance role at uniQure. The VP 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). Responsibilities
Develop and implement the global Strategic Quality Plan. Set quality requirements for corporate objectives and provide strategic leadership supporting these requirements. Ensure company-wide compliance with applicable regulations. Design and implement a strategic audit plan for all uniQure 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. Direct 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. Support 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 management, motivation, recruitment and evaluation of personnel. Define, implement, maintain and continuously improve processes and systems, supported by meaningful KPIs. Interact with staff of other disciplines 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 in pharma/biotech or related sector in a Quality role with 10+ years in a leadership role directing a Quality Unit Industry experience in biologic products is required Expert knowledge of US, EU and ICH GxP guidelines Strong scientific background in biosciences and gene therapy and/or live viral vaccine experience is desirable Experience in leading and hosting regulatory inspections and interactions (FDA at minimum, EMA preferred) Proven experience with new site development, commissioning, qualification, and validation Understanding of phases and processes used to execute pre-clinical and clinical studies Core competencies
Ability to analyze data from various sources to support decisions and align with the organization's strategy Ability to balance broad change with organizational feasibility; set realistic goals and implementation plans Ability to set clear, challenging goals and drive improved performance Comfortable with ambiguity; adapt and lead through complex situations Willingness to take smart risks with data and input from others High integrity and forethought in decision-making Ability to attract and recruit top talent, motivate the team, delegate effectively, and manage performance Perseverance and relentless commitment to higher standards Self-reflection, continuous improvement mindset, and leading by example Strong emotional intelligence and clear, persuasive communication Inspiring trust and followership through influence and passion Seniority & Employment
Seniority level: Executive Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Vice President, Global Quality Assurance role at uniQure. The VP 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). Responsibilities
Develop and implement the global Strategic Quality Plan. Set quality requirements for corporate objectives and provide strategic leadership supporting these requirements. Ensure company-wide compliance with applicable regulations. Design and implement a strategic audit plan for all uniQure 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. Direct 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. Support 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 management, motivation, recruitment and evaluation of personnel. Define, implement, maintain and continuously improve processes and systems, supported by meaningful KPIs. Interact with staff of other disciplines 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 in pharma/biotech or related sector in a Quality role with 10+ years in a leadership role directing a Quality Unit Industry experience in biologic products is required Expert knowledge of US, EU and ICH GxP guidelines Strong scientific background in biosciences and gene therapy and/or live viral vaccine experience is desirable Experience in leading and hosting regulatory inspections and interactions (FDA at minimum, EMA preferred) Proven experience with new site development, commissioning, qualification, and validation Understanding of phases and processes used to execute pre-clinical and clinical studies Core competencies
Ability to analyze data from various sources to support decisions and align with the organization's strategy Ability to balance broad change with organizational feasibility; set realistic goals and implementation plans Ability to set clear, challenging goals and drive improved performance Comfortable with ambiguity; adapt and lead through complex situations Willingness to take smart risks with data and input from others High integrity and forethought in decision-making Ability to attract and recruit top talent, motivate the team, delegate effectively, and manage performance Perseverance and relentless commitment to higher standards Self-reflection, continuous improvement mindset, and leading by example Strong emotional intelligence and clear, persuasive communication Inspiring trust and followership through influence and passion Seniority & Employment
Seniority level: Executive Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing
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