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Associate Director R&Amp;D Quality Assurance

Location: Amsterdam
Language(s): Only English Required
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17 Oct 2020
Associate Director R&D Quality Assurance

Location: Amsterdam (Netherlands)

Job category: Quality Assurance

uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.

Purpose of the role

uniQure seeks an integrative, collaborative, and patient-centric thinker for a key role in Quality Assurance support of pre- and non-clinical development. In this position, you will design, implement, and manage risk-based Quality Systems to efficiently support in-house development laboratories supporting GLP and GCP studies. You will also provide quality and compliance leadership to internal teams, uniQure consultants, and external vendors.

Key result areas (major duties, accountabilities and responsibilities)

• Provide R&D Quality Assurance support to bioanalytical assay development, execution, and transfer.
• Provide QA oversight of internal and contract laboratories supporting GLP and GCP studies.
• Collaborate with cross-functional teams to identify, prioritize, and remediate compliance gaps and risks.
• Develop and implement risk-based audit and oversight strategies for GLP and GCP laboratory vendors and internal processes.
• 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 GLP at vendors
• 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:

• S. Degree in biology, chemistry, or an allied health field with at least in 8 years in the pharmaceutical or biopharmaceutical industry.
• S Degree in biology, chemistry, or an allied health field with at least 6 years in the pharmaceutical or biopharmaceutical industry.
• Expertise in application of global GLP standards is mandatory. Expertise in global GCP standards is desirable.

Core Competencies:

• 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