Clinical Quality Operations Manager

Role Overview

• Responsible for process and performance management related to the delivery of the operational function(s), as assigned.
• Overseeing the strategic implementation of quality by design principles in assigned clinical trials.
• Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM).
• Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends.
• Responsible for ensuring comprehensive oversight of all activities delegated to third parties.
• Facilitating and monitoring CTT oversight of vendors.
• Developing, reviewing and revising quality agreements with business partners.
• Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations.
• Facilitating and overseeing responses to audit and inspection observations as appropriate.
• Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies.
• Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide.
• Contributing to the development and/or revision of Sponsor policies, SOPs and training materials.
• Developing the strategy for management/support for GCP inspections of Sponsor products.

Requirements

• Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
• Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Experience with delivering effective CAPA management solutions.
• Experience with risk management tools and processes within the clinical quality framework.
• Fluent in English, both written and verbal.
• Experience in Risk Management and Quality Management in Phase I.
• Relevant clinical research experience in a pharmaceutical company or CRO: Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO.
• Thorough knowledge of drug development process.
• Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
• Thorough project management, change management, line management experience, and quality control experience highly desirable.
• Individual is familiar with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being highly desirable.
• Relevant quality management experience: Detailed knowledge of all aspects of GCP guidelines and regulations.
• Demonstrated ability to separate critical from non-critical GCP issues.
• Demonstrated effectively balance quality and speed in complex situations.
• Relevant leadership and process skills: Demonstrated ability to work in a team environment.
• Demonstrated ability to work under pressure and requires minimal supervision.
• Strong interpersonal and communication skills.
• Strong negotiation skills and ability to influence stakeholders across functions.
• Strong analytical skills.
• Excellent planning and organizational skills.
• Excellent oral, written and presentation skills.

Tech Stack

• Google Cloud Platform

Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple ERG’s (employee resource groups)