Director, Corporate Quality

UniQure NV; Lexington (MA); On-site; USD 205,000 - 265,000; Full time

Job summary

uniQure seeks a Director of Corporate Quality to lead the global QMS and ensure compliance with cGMP across the organization, aligning processes with company strategy. You will oversee audits, CAPA, change control, training, data integrity, and vendor qualification, while partnering with regulators and internal stakeholders to enable safe, scalable gene therapy medicines.

This leadership role requires building a high-performing team, driving continuous improvement, and delivering clear metrics

Qualifications

• 15+ years GMP experience in pharma/biotech quality roles.
• 10+ years leadership directing quality teams and operations.
• Bachelor's or master's in Life Sciences or Engineering.

Responsibilities

• Oversee global QMS to ensure compliance with cGMP and company strategy.
• Lead CCRB, change control, CAPA, deviations, and audits.
• Partner with regulatory agencies for inspections and licensing.
• Develop and maintain a high-performing quality organization.

Skills

GMP knowledge

Regulatory inspections

Leadership

Data integrity

MS Office

Education

Life Sciences or Engineering degree

Tools

Validation software

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 [e-mail].
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 [e-mail].
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.