Clinical Quality Operations Manager, FSP

Job Overview:

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.

Summary of Responsibilities:

• Operational Quality Management:

• The Clinical Quality Operations Manager is responsible for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
• The CQOM will be the single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM). E.g. risk assessment and categorization, risk responses and analyses and critical to quality factors.
• The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
• The CQOM is responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to:
  • Facilitating and monitoring CTT oversight of vendors
  • Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
  • Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations (e.g. NGO, government or academic institutions).
• The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyse data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
• In collaboration with the CQOL, the CQOM will develop skillsets in order to be able to recognise and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a profound understanding of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials).
• The CQOM will build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with MRL QA and acting as the link between Clinical Development, study teams, global business functions and regional study management.
• The CQOM, in collaboration with peers, will contribute to the standardisation of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.

• Inspection Preparation and Management:

• The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
• The CQOM is responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
• Collaborate with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Develops, updates, and maintains GCP inspection procedures and guidelines within GCTO.
• Contributes to the development and/ or revision of Sponsor policies, SOPs and training materials.
• Develops the strategy for management/support for GCP inspections of Sponsor products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance.
• Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, PV, GRACS, IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
• In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
• Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
• Escalates potentially significant inspection findings/compliance risks/impact to Sponsor Senior Management.
• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

• CAPA Management Support:

• Ensures that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion.
• Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
• Provides guidance and support for CCQMs regarding inspections at a country level sites that require a Sponsor headquarters input.

• Other activities:

• Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
• Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

Qualifications (Minimum Required):

• 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 (Minimum Required):

• Expertise 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.

YOU NEED TO BRING...

• Bachelors/Master's Degree (life science or similar preferred).

• Excellent communication, leadership, and project management skills.

• ACRP-CP Certification strongly preferred

• 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.

Experience:

• 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 earlydevelopment trials (FIH, SAD/MAD preferred)

• Practical application of riskbased quality management (risk assessments, CtQ focus, tailored monitoring)

• Strong understanding of participant safety and doseescalation controls

• Proven ability to identify, escalate, and mitigate risks proactively

• Comfort working crossfunctionally in fastpaced, evolving environments

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• Paid time off (PTO)

• Employee recognition awards

• Multiple ERG's (employee resource groups)

• Salary range of 120-132,000k USD

Physical Demands/Work Environment:

• Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Frequent travel to clients/ site locations with occasional travel both domestic and international.

• Travel requirements: 20%

  Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

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