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 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.