Associate Director, Clinical Quality & Compliance

Our client is a leading Global Biopharma with a Clinical Trial Centre of Excellence based in Dublin City Centre. They play a crucial role in developing life-saving therapies as they strive to cure unmet medical needs. They are global leaders in the development of therapies in the areas of Infectious Diseases, Oncology & Inflammation.

They are looking for an experienced Associate Director with extensive GCP auditing experience to join their Clinical Quality Business Partner team who is ready to dive-in to support their therapeutic areas and clinical development programs. In this role you will represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk. The full title of the role is:Associate Director, Clinical Quality Business Partner, Therapeutic Area Support.

This role is suited to candidates who possess expert Good Clinical Practice (GCP) knowledge, strong project management and communication skills, strategic thinking ability and proven success in a matrixed organization.

As part of Global R&D Quality & Medical Governance you will be joining a supportive team that fosters constructive collaboration in support of our clinical development programs promoting a culture of quality.

Role/Responsibilities:

• Serve as Clinical Quality Business Partner lead for assigned clinical trial programs. Handle multiple projects and ensure overall and timely completion of tasks.
• Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
• Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
• Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
• Leads/Assists in readiness preparation, and/or directly support regulatory agency inspection. Leads/Assist in coordination of response to any findings.
• Lead deviation identification, reporting, and CAPA development.
• Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
• Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
• Fosters a commitment to quality in individuals and a culture of quality within the organization.
• Oversee work of others as needed.

• BA or BS and 10+ years of relevant experience (8+ years of relevant experience with an applicable MS).
• At least 6 years of audit and compliance experience.
• Must have significant GCP audit and compliance experience.
• Bio-pharma sponsor experience preferred.
• Recognized as an expert resource on a range of clinical compliance topics.
• Strong verbal and written communication skills and interpersonal skills.
• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
• Excellent organization skills and project management.
• Able to work equally well as part of a team or independently
• Ability to travel approximately 10% required.