Associate Director, R&D Quality Assurance
Associate Director, R&D Quality Assurance Location : Lexington, 113 Hartwell Ave Education level : Bachelor / Graduate Job category : Corporate Quality Target start date : 6 / 10 / 2024 Work Location : On-Site Shift : 1st
uniQure seeks an integrative, collaborative, and patient-centric thinker for a key role in Quality Assurance support of global clinical development programs, pharmacovigilance activities, and non-clinical development.
In this position, you will design, implement, and manage risk-based Quality Systems to efficiently support GCP, GLP, and GVP compliance.
You will also provide quality and compliance leadership to internal clinical trial teams, uniQure consultants, and external vendors.
A summary of the major responsibilities :
- Represent R&D Quality Assurance on cross-functional clinical trials teams and product development teams
- Collaborate with cross-functional teams to identify, prioritize, and remediate GCP, GLP, and GVP compliance gaps and risks.
- Develop and implement risk-based audit and oversight strategies for clinical and non-clinical vendors, internal processes, and clinical investigator sites.
- Manage routine audit conduct by external consultants
- Lead high-complexity and high-risk audits where uniQure representation is required.
- Lead cross-functional investigations, root cause analysis, and CAPA development for significant departures from GCP, GLP, and GVP
- Collaborate with supported functions to develop and implement inspection readiness plans.
- Lead quality and compliance awareness throughout the uniQure organization by example and by coordinating cross-functional training opportunities.
- Approximately 20% domestic and international travel required.
Qualifications :
- B.S. Degree in a medical or allied health field with at least in 8 years in the pharmaceutical or biopharmaceutical industry.
- M.S Degree in a medical or allied health field with at least 6 years in the pharmaceutical or biopharmaceutical industry.
- Expertise in application of global GCP standards is mandatory. Expertise in global GLP and GVP standards is desirable.
Core Competencies :
- A commitment to promoting the rights and well-being of patients and human research subjects.
- A passion for bringing innovative therapies to patients with serious unmet medical needs.
- Experience with leading execution of risk-based quality and compliance strategies.
- Strong ability to prioritize and operate with a sense of urgency.
- Effective communication and interpersonal skills, including the ability to interact with all levels of the uniQure organization.
- Demonstrated ability to develop practical solutions in a dynamic and innovative environment.
- Exhibits integrity and commitment to high ethical and compliance standards
- A sense of humor
Our benefits
At uniQure, we offer competitive benefits packages that are designed to attract and retain bright, talented people. While they vary by location, below are a few of the benefits offered as part of our comprehensive package for our U.S. employees :
- Medical, Dental, and Vision plans with the majority of premiums paid by the company
- Stock Options and Bonus programs
- 401(k) Retirement Savings Plan with company match
- Generous paid time off with up to four weeks of vacation, plus holidays
- 100% company-paid life insurance and short-term and long-term disability
- Dependent Care and Health Flexible Spending Accounts
- Tuition Reimbursement
- Fitness Membership Reimbursement
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