Director, Corporate Quality

Regulatory Jobs; Lexington (MA); Hybrid; USD 205,000 - 265,000; Full time

Job summary

uniQure is seeking a Director of Corporate Quality to oversee the global Quality Management System (QMS) and ensure adherence to global cGMP regulations. This role leads Quality Systems, training, risk management, and data integrity across the organization to support transformative gene therapy medicines.

The Director will build a high-performing Quality organization, provide strategic vision for growth, and act as main contact for regulatory agencies during inspections and licensing.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or Engineering.
• 15+ years of GMP experience in pharma/biotech in a Quality role.
• 10+ years in a leadership role directing and managing Quality teams and operations.

Responsibilities

• Oversee the global Quality Management System (QMS) to ensure compliance with global regulations.
• Facilitate CCRB and oversee timely execution and closure of changes and Quality items.
• Ensure data integrity across the organization and management of training/documentation.
• Lead risk management activities and advise stakeholders on regulatory requirements.
• Coordinate internal and external inspection readiness and responses to observations.
• Build and maintain relationships with Regulatory Agencies for inspections and licensing.

Skills

GMP compliance

QMS management

Audits & inspections

Data integrity

Leadership

Education

Bachelor’s/Master’s in Life Sciences or Engineering

Tools

MS Office suite

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
• Oversees 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 Agenciesin 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)

#LI_Hybrid

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].