Associate Director, Quality GCP

Verastem; Boston (MA); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Verastem Oncology is looking for a seasoned GCP Quality Assurance professional to lead audits, risk-based QA strategies, and inspection readiness across clinical programs. You will partner with internal teams to ensure compliance, review SOPs and templates, and drive continuous quality improvement in a dynamic biotech setting.

Candidates should have 7+ years in drug/biologics development, deep GCP knowledge, and ability to travel up to 50%.

Competenze

• 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.

Mansioni

• 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).
• 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.

Conoscenze

GCP QA

Audit management

Vendor oversight

Regulatory knowledge

Cross-functional collaboration

Formazione

B.S./B.A. in Life Sciences

Advanced degree preferred

Strumenti

Veeva systems

Descrizione del lavoro

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.