Associate Director, Quality GCP

Verastem•Boston, MA

About The Position

The Associate Director, Quality GCP develops and implements quality programs and risk-based GCP strategies across clinical programs and studies. The role manages or supports the development, review, enhancement, and implementation of GCP quality standards and controlled documents, and promotes quality and compliance across the company. It builds relationships with internal and external partners and provides GCP guidance to internal stakeholders and Study Management Teams. The position plans, conducts, and manages audits of clinical trial sites, vendors, and internal processes, including audit follow-up. It also coordinates external auditors with internal stakeholders, supports clinical vendor and site oversight, conducts or facilitates GCP quality event investigations, and contributes to inspection readiness and clinical risk management. The Associate Director leads or supports clinical quality metrics, quality and compliance training, and process improvement initiatives. Other duties may be assigned by Quality Assurance Management.

Requirements

Bachelor’s degree in a related Life Sciences discipline.
At least 7 years in drug/biologics development in the biotechnology or pharmaceutical industry.
At least 4 years of 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 and experience planning, conducting, and reporting clinical site and service provider audits.
Ability to identify quality issues or discrepancies and manage and resolve them proactively and effectively 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, strong attention to detail, and the ability to manage complexity and multiple tasks.
Strong interpersonal and organizational skills and excellent verbal and written communication skills.
Ability to travel 30–50% domestically and internationally.

Nice To Haves

Advanced degree preferred.
Additional related experience in GLP and/or GVP Quality Assurance preferred.
Experience with Veeva systems is a plus.

Responsibilities

Develop and implement Quality Programs where needed.
Develop and implement risk-based GCP strategies across clinical programs and/or studies.
Manage or actively support the development, enhancement, review, and implementation of GCP quality standards and controlled documents, such as SOPs, Work Instructions, and Templates.
Promote compliance and quality throughout the company and represent the 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 such as reports and corrective actions.
Coordinate and communicate with internal stakeholders and external auditors to ensure externally conducted audits fulfill business needs.
Partner with clinical stakeholders to manage clinical vendor and/or clinical site oversight and issue management.
Conduct and/or facilitate investigations of GCP Quality Events; collaborate with subject matter experts on root cause analysis and 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 to implement and manage the Clinical Risk Management Program.
Lead or contribute to developing and maintaining key Clinical Quality Metrics for 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.
Perform other duties as assigned by Quality Assurance Management.