Job description

ESSENTIAL DUTIES AND RESPONSIBILITIES

Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance
Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc. to influence effective processes and program oversight
Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd parties. Provide training and support for inspections at sites, CROs and service providers
Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial “essential documents” (e.g. protocols, ICF, etc.)
Evaluate vendors for potential use; conduct and/or manage qualification inspections of GCP suppliers and service providers
Create and execute clinical study audit plans, perform routine and for-cause audits of clinical investigator sites, and review of TMFs and CSRs
Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. Create, monitor, and improve a QMS with focus on development phases
Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
Lead, investigate, and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews
Participate in department cross-training and lead/support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs
Other duties as assigned

REQUIREMENTS
Education

BS/MS or equivalent in a relevant scientific discipline. Graduate level in a science or engineering related discipline preferred

Experience

10 -12+ years’ experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years’ experience in an out-sourced environment
Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards
5+ years’ experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable
Has a bias for action and display a sense of urgency
Must possess strong skills in leadership, communication, project management, and budget management
Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties
A working knowledge of databases, including Electronic Document Management Systems (EDMS), is desirable
In?depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
SQA RQAP certification is a plus
Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance
Additional certifications as an auditor as well as training regulatory frameworks highly desirable.
Expertise in data integrity and CFR Part 11 required
Ability to travel 10-30% domestically and internationally