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

uni

Qure 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, uni

Qure 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 uni

Qure 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 uni

Qure 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 uni

Qure 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