Associate Director, Clinical Quality Assurance

Overview:

Job Title: Associate Director, Clinical Quality Assurance

Reports to: Executive Director, Quality Assurance

Location: EMEA (Remote)

Are you a meticulous QA professional passionate about ensuring the highest standards of GCP compliance in clinical trials? Do you thrive on driving quality improvements and preparing for regulatory inspections? Are you ready to make a significant impact on oncology treatments?

If so, join our team and be our next Associate Director, Clinical Quality Assurance, apply now

About the Role:

We are seeking a highly motivated and experienced Associate Director, Clinical Quality Assurance to join our team, reporting to the Executive Director, Quality Assurance. This critical role will serve as the lead for compliance with GCP requirements for specific clinical programs and trials , providing essential GCP QA support on an as-needed basis to different trials. Your responsibilities will span from QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator's Brochure, Informed Consent Form, Trial Master File) , as well as relevant submission documentation.

You will facilitate the assessment and investigation of quality issues by driving root cause analysis and remediation, providing expertise and recommendations, and ensuring timely closure of quality issues. Furthermore, you will facilitate the review of potential Serious Breach and Urgent Safety Measure assessments arising from assigned clinical programs. This is an exciting opportunity to contribute to building and shaping Menarini Stemline's Oncology business.

Responsibilities:

• Responsible for QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator's Brochure, Informed Consent Form, Trial Master File).
• Drive the assessment and investigation of quality issues, including root cause analysis, remediation, and timely closure.
• Facilitate the review of potential Serious Breach and Urgent Safety Measure assessments.
• Coordinate GCP/GVP vendor audits and contribute to the impartial management of the audit program, including risk-based site selection and ensuring proper audit execution and closure. Ensure that any issues identified through audits that are not resolved in time for audit close-out are appropriately tracked and managed as CAPA. You will also determine if clinical site audit observations may represent trial-wide or program-wide risks and ensure impact/risk assessments and trial-wide/program-wide CAPAs are adequate.
• Oversee quality with Functional Lines and vendors, including facilitating Quality Oversight Committee meetings and providing input to Quality Systems reviews.
• Collaborate on the implementation of risk-based quality management (RBQM) for specific studies, covering critical data identification, QTLs, and reporting.
• Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis, strategy development, program management, and providing key support during and after Health Authority inspections.
• Provide guidance, training, and input on compliance issues using expertise in GCP, clinical development, and industry best practices.
• Support GCP SOP development, implementation, and maintenance by serving as a Quality reviewer.

Qualifications:

• Bachelor's Degree in a scientific field, master's degree in clinical research a plus.
• 5+ years' experience in the pharmaceutical industry.
• Oncology experience preferred.
• Registration as a Registered Assurance Quality Professional (RQAP) in GCP expected.
• Working knowledge of clinical research practices within the US and the EU/UK, experience in other regions will be considered a plus.

As a person, you are adaptable, able to develop creative and effective solutions to solve problems.

Elevate Your Impact:

If you are a passionate and skilled project management professional seeking a challenging and rewarding opportunity to contribute to the advancement of oncology treatments, we encourage you to apply. Join us and be a part of a team that is making a difference in the lives of patients.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees