Associate Director, Quality GCP

Responsibilities: 

• Develop and implement Quality Programs where needed 

• Develop and implement risk-based GCP strategies across clinical programs and/or studies 

• Manage and/or actively support the development, enhancement, review, and implementation of GCP quality standards, and controlled documents (e.g., SOPs, Work Instructions, Templates) 

• Promote compliance and quality throughout the company and represent in Quality Department in internal meetings and events.  

• 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 ; 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 . 

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