Clinical Quality Operations Manager - Remote

Clinical Quality Operations Manager

In partnership with the Clinical Quality Operations Lead and Head of Clinical Quality Operations, the Clinical Quality Operations Manager is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The Clinical Quality Operations Manager 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 Clinical Quality Operations Manager will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach. The Clinical Quality Operations Manager will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, managing, and following up on regulatory inspections.

Responsibilities include:

• 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 Clinical Trial Team.
• Performing a TA-level review of quality plans and risk mitigation approaches to identify emerging signals or trends.
• Facilitating and overseeing responses to audit and inspection observations.
• Developing skillsets to recognize and respond to new and emerging risks through the use of technology.
• Building effective working relationships with key stakeholders to ensure role clarity and business effectiveness.
• Contributing to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.
• Maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide.
• Developing, updating, and maintaining GCP inspection procedures and guidelines.
• Ensuring that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection.
• Maintaining the global inspection tracking system.
• 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.
• Providing guidance and support for Clinical Quality Operations Managers regarding inspections at a country level site that requires a Company headquarters input.
• Providing input into the GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans, and Regulatory Health Authority inspections status and results.
• Leading, driving, facilitating, and/or supporting remediation, prevention activities as process improvement and training, as needed.

Education:

• B.A./B.S. or M.A./M.S. Degree or equivalent in a relevant health care area. Further formal education in quality management or business management is preferred.

Prerequisites:

• 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.

Skills:

• 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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.