Bachelor's degree in Life Sciences; advanced degree preferred.
7+ years in drug/biologics development within biotech or pharmaceutical sectors.
4 years of GCP Quality Assurance experience in Clinical Research and Development.
Experience in leading Inspection Readiness Programs and related activities.
In-depth knowledge of GCP EU, FDA, and ICH regulations and guidelines.
Strong experience in planning and conducting clinical audits.
Familiarity with Veeva systems is a plus.
Responsibilities
Develop and implement Quality Programs as needed.
Create risk-based GCP strategies for clinical programs and studies.
Manage and enhance GCP quality standards and controlled documents.
Promote compliance and represent the Quality Department in meetings.
Build and maintain relationships with internal and external partners.
Conduct audits of clinical trial sites and vendors, managing follow-up activities.
Partner with stakeholders for clinical vendor oversight and issue management.
Facilitate investigations of GCP Quality Events and develop corrective action plans.
Support Inspection Readiness activities for internal teams and clinical sites.
Lead the development of Clinical Quality Metrics for process improvement initiatives.
Benefits
Comprehensive health insurance options.
Flexible work arrangements.
Professional development opportunities.
Collaborative and innovative work environment.
Travel opportunities for professional growth.
Full 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.
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.
