This remotely based position serves as the primary Quality and Compliance Office contact for Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) compliance support for Early Development therapeutic area and clinical study teams. The key accountability of the role is to provide compliance expertise and guidance regarding regulatory requirements, GCP guidelines and Standard Operating Procedures (SOPs) for the conduct of clinical studies. In this role the incumbent:
Provides expertise and strategic guidance for the conduct of Early Clinical Development study programs and establishes measures that will enhance compliance and successful clinical trial conduct.
Operates as a trusted partner and member of clinical study teams providing team leadership, oversight, guidance and subject matter expertise.
Utilizes a risk-based strategy to identify and escalate compliance issues to leadership; executes effective and comprehensive action plans to address quality and compliance risks.
Develops relationships with key internal business partners and stakeholders: Quality, Regulatory, Safety, Vendor Alliance Management, and other key functions to enable transparency, escalation, and resolution of quality and compliance matters.
Fosters an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.
Provides expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Bachelor’s degree, preferably in a scientific, health sciences or quality related field.
12+ years of relevant experience in a pharmaceutical drug development, GCP related discipline, or equivalent combination of advanced degree and experience.
Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines.
Experience in managing clinical quality and GCP compliance issues and expert knowledge of the drug development process.
Experience with cross-functional problem solving and driving change through to successful implementation.
Experience with cross-functional stakeholder management with the ability to influence and negotiate in a matrix organization. Ability to build and sustain meaningful relationships with business stakeholders and partners.
Demonstrated strength in analytical and strategic assessment of regulatory compliance risks with the ability to articulate potential business impact. Flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
Background in compliance and computer systems validation (21 CFR Part 11) is desired, but not required.
Strong computer literacy in programs such as MS Word, Excel, Project, Visio and PowerPoint.
Ability to travel as needed.