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.

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Location

Boston, Massachusetts (Hybrid)

Employment Type

Full-Time

Compensation

170K-200K

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