About this opportunity
UniQure NV lists this Director, Corporate Quality opportunity in lexington, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
uniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible for improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high-quality standards and by recognizing the sense of urgency in areas of high unmet medical need.
Place in the Organization
The Director of Corporate Quality is responsible for oversight of the global Quality Management System (QMS), ensuring processes adhere to global cGMP regulations. This includes oversight of all QMS functions including but not limited to Metrics & Management Review, Quality Systems (e.g., Deviation, Change Control, CAPA), Document Control, Records Management, Training, Risk Management, Data Integrity & IT Quality, Vendor Qualification and Internal/External Audit Management.
The Director, Corporate Quality is responsible for building and motivating a high performing and innovative organization which enables a culture of compliance, trust and accountability, efficient execution, collaboration for success, and integrity and respect in order to deliver transformative gene therapy medicines.
Key Result Areas (major Duties, Accountabilities And Responsibilities)
Manages development, implementation, maintenance, and improvement of all relevant Quality Management Systems and processes to ensure compliance in line with global regulations and in alignment with the company’s strategy
Facilitates Change Control Review Board (CCRB) and provides oversight for timely execution and closure of changes. Facilitates issuance and tracking of Quality Management items (e.g., Dev, CAPA, OOS) and holds stakeholders accountable for closure on agreed timelines
Responsible for computer system validation activities in support of Quality initiatives
Responsible for data integrity across the organization
Maintenance of training and documentation processes
Overseas the risk management process to ensure compliance with current regulations
Provides Quality and corporate department stakeholders guidance that is aligned with global regulations and internal Quality Management Systems
Provides strategic vision to influence the growth and development of uniQure capabilities needed to support a fully commercial gene therapy company
Responsible for developing, implementing and improving Quality System Metrics and for reporting performance trends and risks to senior management
Responsible for developing, implementing, and improving a risk based internal and external audit program
Responsible for internal inspection readiness activities
Responsible for coordinating effective and timely internal stakeholder responses to inspection observations
Responsible for assessing the impact of any new or updated regulations on the company’s Quality Management Systems
Responsible for developing and maintaining a high-performing Quality organization to effectively execute organizational responsibilities
Act as the main contact person for local and international Regulatory Agencies in relation to inspections and licensing and manage these relationships effectively
Qualifications Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
15+ years of relevant GMP experience in the pharma/biotech industry in a Quality role
10+ years’ experience in a leadership role directing and managing Quality teams and operations
Core Competencies Advanced knowledge of global GMP guidelines
Strong computer system validation and data integrity knowledge
Experience in leading and hosting regulatory inspections and interactions
Demonstrated leadership in building and leading high-performance teams
Ability to collaborate and influence to effect change both within and outside the organization
Confident, independent, self-starter, proactive, and results-orientated with high-performance standards
Solid organizational, analytical and problem-solving skills
Ability to work well with diverse groups
Ability to multi-task in a fast-paced environment with changing priorities
Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
US Salary Range
$205,000—$265,000 USD
uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact
uniQure posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure’s Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via
uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information — including disclosures for California residents under the CCPA and for applicants under the GDPR — please review our applicant privacy notice. #J-18808-Ljbffr
Worksite address
lexington, MA, 02173, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.