Clinical Quality Operations Manager, Oncology

MSD • Rahway, NJ

5d • Remote

About The Position

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Overarching Tasks: It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Requirements

• Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.
• Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Has delivered effective CAPA management solutions.
• Has worked with risk management tools and processes within the clinical quality framework.
• Superior oral and written communication skills in an international environment.
• Ability to manage and develop others, including formal performance management when necessary.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
• Ability to lead cross-functional teams of business professionals within and outside our Research division.
• Able to act urgently for worldwide health authority inspection matters.
• Ability to analyze, interpret and solve complex problems.
• Ability to think strategically and objectively and with creativity and innovation.
• Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
• Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
• Adaptability
• Clinical Quality Management
• Clinical Study Design
• Clinical Trial Planning
• Clinical Trials Monitoring
• Data Analysis
• ICH GCP Guidelines
• Medical Writing
• Process Improvements
• Regulatory Compliance
• Risk Management
• Strategic Planning
• Strategic Thinking
• Team Leadership
• Training and Development

Nice To Haves

• Further formal education in quality management or business management is preferred.

Responsibilities

• Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
• Developing Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
• Facilitating and overseeing the responses to audit and inspection observations.
• Analyzing data across therapy areas to identify signals and trends and developing and implementing appropriate process improvement strategies.
• Building and enabling effective working relationships with key stakeholders.
• Contributing to the standardization of Clinical Quality Operations procedures, tools and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.
• Facilitating and monitoring CTT oversight of vendors.
• Development, review and revision of quality agreements with business partners.
• Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations.
• Maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide.
• Maintaining appropriate levels of knowledge and skill to effectively lead and support GCP inspections, worldwide.
• Monitoring, interpreting and communicating key regulatory developments within CQO.
• Providing comprehensive oversight of the TA.
• Maintaining contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Developing, updating, and maintaining GCP inspection procedures and guidelines within GCTO.
• Contributing to the development and/or revision of Company policies, SOPs and training materials.
• Developing the strategy for management/support for GCP inspections of Company products.
• Ensuring that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
• Maintaining and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
• Acting as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management.
• Escalating potentially significant inspection findings/compliance risks/impact to Company Senior Management.
• Developing the inspection management plan for each assigned and identified Regulatory Health Authority inspection.
• Ensuring that all actions and commitments related to audits and inspections are implemented in a timely manner.
• Tracking all inspection CAPA and regulatory commitments and checking evidence of completion.
• Ensuring repository of evidence is complete for all Regulatory Health Authority inspections.
• Providing guidance and support for CCQMs regarding inspections at a country level sites that require a Company headquarters input.
• Providing input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results.
• Assessing and providing input to strengthen company programs/strategies with an aim to increase Inspection Readiness.
• Leading, driving, facilitating and/or supporting remediation, prevention activities as process improvement and training, as needed.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree