Job Description

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 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.