Clinical Quality Operations Manager, FSP

Fortrea•Durham, NC

10h•$120,000 - $132,000•Onsite

About The Position

Responsible for process and performance management related to the delivery of the operational function(s), as assigned. Success in this role will require close and cross-functional collaboration with the Managers and Senior Managers Quality Control, RCQA and other functional leaders, including GCTO, Project Management, Clinical Team leads and with other functions as appropriate to ensure that the contract specified activities conducted by these departments meet or exceed all obligations defined by the project contract.

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.
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.
Expertise in Risk Management and Quality Management in Phase I.
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.
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.
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.
Bachelors/Master's Degree (life science or similar preferred).
Excellent communication, leadership, and project management skills.
Strategic thinker with strong problem-solving and analytical abilities.
Effective in cross-functional collaboration and inspection readiness.
Skilled in summarizing audit/inspection findings and delivering lessons learned.
6+ years in clinical research, including 2+ years in clinical quality and inspection management.
Expert knowledge in clinical development, QMS, GCP/ICH, and global regulatory requirements.
Experience with CAPA and risk management tools.
Must have participated in regulatory audits and regulatory inspections.
Demonstrated experience supporting Phase I or early‑development trials (FIH, SAD/MAD preferred).
Practical application of risk‑based quality management (risk assessments, CtQ focus, tailored monitoring).
Strong understanding of participant safety and dose‑escalation controls.
Proven ability to identify, escalate, and mitigate risks proactively.
Comfort working cross‑functionally in fast‑paced, evolving environments.

Nice To Haves

ACRP-CP Certification strongly preferred

Responsibilities

Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Serving as the single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM), including risk assessment and categorization, risk responses and analyses, and critical to quality factors.
Collectively and periodically performing a TA-level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide feedback.
Ensuring comprehensive oversight of all activities delegated to third parties, including 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 with non-commercial organizations.
Facilitating and overseeing responses to audit and inspection observations.
Analyzing data across therapy areas to identify signals and trends and developing/implementing process improvement strategies.
Developing skillsets to recognize and respond to new and emerging risks through technology, with a focus on Good Clinical Practice (GCP) and digital data management.
Building and enabling effective working relationships with key stakeholders, including MRL QA, Clinical Development, study teams, and global business functions.
Contributing to the standardization of Clinical Quality Operations procedures, tools, and templates.
Maintaining current regulatory inspection knowledge related to GCP inspections by regulatory agencies worldwide.
Leading and supporting GCP inspections worldwide.
Monitoring, interpreting, and communicating key regulatory developments within CQO.
Collaborating with other therapeutically aligned CQOMs to provide comprehensive oversight of the TA.
Maintaining 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 Sponsor policies, SOPs, and training materials.
Developing the strategy for management/support for GCP inspections of Sponsor products to ensure consistent, professional, and proactive handling of all phases of Regulatory Health Authority inspections.
Ensuring a cross-functional team is informed and prepared to support any Regulatory Health Authority inspection.
Maintaining and QCing the global inspection tracking system.
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 Sponsor Senior Management.
Developing the inspection management plan for each assigned and identified Regulatory Health Authority inspection.
Ensuring 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 the repository of evidence is complete for all Regulatory Health Authority inspections.
Providing guidance and support for CCQMs regarding inspections at country-level sites that require Sponsor 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 to increase Inspection Readiness.
Leading, driving, facilitating, and/or supporting remediation, prevention activities as process improvement and training, as needed.