Director, Quality

• Bachelor’s degree with a minimum of 7 years of experience, A scientific, life science, or technical degree is preferred, or equivalent combination of education, training and experience that provides the individual the required knowledge, skills, and abilities.
• Advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as quality and compliance risk assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Advanced clinical trials quality experience.
• Leadership and people management as part of a matrixed organization.
• Demonstrated experience using standard applications supporting Quality activities (e.g., Quality Management System, Risk Management System, Audit Management System).
• Strong interpersonal skills, ability to influence, and ability to build and maintain excellent working relationships and demonstrated success working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.
• Demonstrated understanding of clinical development process and ICH-GCP (Good Clinical Practice), GXP
• Working knowledge of medical terminology, physiology and pharmacology and excellent knowledge of applicable US and international trial regulations and guidelines.
• Effective leadership skills, including advanced organization and communication, problem-solving, decision-making, negotiation, and prioritization.
• Strong project management skills, including program management, and advanced communication and presentation skills. Innovative and strategic thinker.
• Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required.
• Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results.
• Excellent verbal and written communication skills.
• Proficient in Microsoft Office products.
• Ability to travel up to 20% of the time.

Essential Functions/Areas of Accountability

• Responsible for ensuring oversight of organizational Quality Management System (QMS) and quality risk activities and building and managing a quality risk framework that allows for the organization to proactively identify and manage clinical trial quality and establish a regular review of quality metrics.
• Ensure thoughtful and timely implementation of Quality priorities by representing Quality and Compliance at key meetings and overseeing cross-functional projects from a Quality perspective.
• Act as subject matter expert that is able to identify, plan, implement, maintain and evaluate Quality training, including organizational standards and Good Clinical Practice.
• Maintaining visibility into organizational Quality risks and signaling/flagging from various Quality or other metrics to escalate risks to leadership with clear data.
• Continuously improving risk-related systems (technology) and processes, specifically Quality Management reporting, information flow, business processes, and organizational planning, in support of Quality and the organization’s Quality culture.
• Drive consistent development of risk management plans across the organization; identify high-priority risks and risk trends to quality and provide expert consultation on risk management strategies.
• Influence development of new risks and evolving existing risks in relevant Quality Risk Management (QRM) tools.
• Provide feedback to cross-functional roles within the organization to continuously improve Integrated Quality Management Plan (IQMP) approach and other QRM process-related activities.
• Enhance current Quality Management System(s) and create KQIs (key quality indicators) that align with business needs and allow for data driven, risk-based decision-making.
• Assist in developing and presenting Quality risks and management of identified risks at cross-functional governance meetings with the organization.
• Identify and, as needed, develop and maintain resources and applications supporting Quality and Compliance activities.
• Guide direct reports in Quality team to meet organizational goals.
• All other duties as assigned.