Clinical Quality Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for managing processes and performance related to the operational functions assigned.

• Overseeing the strategic application of 'quality by design' principles in clinical trials assigned.

• Serving as the primary contact for clinical trial teams regarding all activities related to risk-based quality management (RBQM).

• Conducting a therapeutic area-level review of quality plans and risk mitigation strategies to detect any emerging signals or trends.

• Ensuring thorough oversight of all activities assigned to third-party vendors.

• Facilitating and monitoring Clinical Trial Team (CTT) oversight of vendors.

• Creating, reviewing, and updating quality agreements with business partners.

• Ensuring that essential elements of the quality management system are established for studies conducted in collaboration with non-commercial organizations.

• Facilitating and overseeing responses to audit and inspection findings as necessary.

• Analyzing data across therapeutic areas to identify signals and trends, then developing and implementing suitable process improvement strategies.

• Keeping up-to-date with current regulatory inspection knowledge pertaining to Good Clinical Practice (GCP) inspections by regulatory bodies worldwide.

• Contributing to the creation and/or revision of Sponsor policies, Standard Operating Procedures (SOPs), and training materials.

• Formulating the strategy for management/support during GCP inspections of Sponsor products.

⛳️ Requirements

• A minimum of 6 years of relevant experience in clinical research, including at least 2 years of direct involvement in developing and managing clinical quality systems and handling regulatory inspections.

• In-depth knowledge and comprehension of clinical development programs, clinical trial processes, as well as quality management systems and quality control tools are essential.

• Expert understanding of GCP/ICH and worldwide Regulatory Health Authority requirements.

• Experience in delivering effective Corrective and Preventive Action (CAPA) management solutions.

• Familiarity with risk management tools and processes within the clinical quality framework.

• Proficient in English, both written and spoken.

• Experience in Risk Management and Quality Management in Phase I clinical trials.

• Relevant clinical research experience in a pharmaceutical company or Contract Research Organization (CRO): at least eight (8) years of relevant clinical research experience in a pharmaceutical company or CRO.

• Comprehensive understanding of the drug development process.

• Strong knowledge of relevant SOPs, ICH, and GCP guidelines.

• Extensive project management, change management, line management, and quality control experience is highly desirable.

• Familiarity with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being particularly advantageous.

• Relevant quality management experience: detailed knowledge of all aspects of GCP guidelines and regulations.

• Proven ability to differentiate between critical and non-critical GCP issues.

• Demonstrated capability to effectively balance quality and speed in complex situations.

• Relevant leadership and process skills: proven ability to collaborate within a team environment.

• Demonstrated ability to work effectively under pressure and requires minimal supervision.

• Strong interpersonal and communication skills.

• Excellent negotiation skills and the ability to influence stakeholders across various functions.

• Strong analytical capabilities.

• Exceptional planning and organizational skills.

• Excellent oral, written, and presentation skills.

🏝️ Benefits

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

• 401(K)

• Paid time off (PTO)

• Employee recognition awards

• Multiple Employee Resource Groups (ERGs)