Associate Director, Quality GCP

* Build, develop, and maintain working relationships with internal and external partners.

* Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Form.

* Plan, conduct and manage audits of clinical trial sites, vendors, and/or internal processes, and associated follow-up activities (e.g., reports, corrective actions). For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.

* Partner with clinical internal stakeholders to manage clinical vendor and/or clinical site oversight and/or issue management.

* Conduct and/or facilitate investigations of GCP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventative action plans, as applicable.

* Support Inspection Readiness activities including preparing internal teams, clinical sites and significant clinical service providers.

* Partner with clinical stakeholders and subject matter experts for the implementation and management of Clinical Risk Management Program.

* Lead or contribute to the development and maintenance of key Clinical Quality Metrics for input into process improvement initiatives and/or presentation to Study Management Teams and Associate Director/Director Leadership.

* Lead the development and delivery of quality and compliance related training to internal functions.

* Provide GCP guidance to internal stakeholders or Study Management Teams, as applicable.

* Participate in quality and/or cross-functional process improvement initiatives, as applicable.

* Other duties as assigned by Quality Assurance Management.

Qualifications:

* Bachelor’s degree in related Life Sciences discipline is required; advanced degree preferred.

* 7+ years in drug/biologics development in the biotechnology or pharmaceutical industry.

* 4 years previous GCP Quality Assurance experience in Clinical Research and Development.

* Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities.

* In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines.

* Strong working knowledge/experience in planning, conducting and reporting clinical site and service provider audits.

* Additional related experience in GLP and/or GVP Quality Assurance is preferred.

* Experience with Veeva systems is a plus.

* Ability to identify quality issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.

* Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

* Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.

* Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.

* Ability to travel 30-50% domestically and internationally.