Clinical Quality Operations Manager

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Key responsibilities:

In collaboration with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is responsible 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 client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be responsible for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach.

The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Operational Quality Management

• Lead implementation ofquality by designand risk-based quality management (RBQM) in clinical trials.
• Serve as primary contact for trial teams on RBQM activities (e.g., risk assessment, CTQs).
• Ensure oversight of third-party activities, including vendor management and quality agreements.
• Support audit/inspection responses and drive cross-therapy area process improvements.
• Collaborate with CQOL to address emerging risks, especially in digital data management.
• Build strong stakeholder relationships across Clinical Development, QA, and global functions.
• Contribute to standardization of CQO tools and procedures.
• Maintain expertise in global GCP inspection requirements (FDA, EMA, MHRA, etc.).
• Lead/support inspections and act as regulatory POC when assigned.
• Develop and maintain inspection procedures, training, and strategy.
• Ensure cross-functional readiness for inspections and manage inspection plans.
• Track global inspection activity and escalate significant findings to senior leadership.

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 client 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.

YOU NEED TO BRING...

• 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.

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

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.

Learn more about our EEO & Accommodations request here.