Quality Manager, Clinical

About the role

This individual contributor role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager. The purpose is to collaborate with global or regional Quality Management teams, functional teams, and other stakeholders to define and execute the global Quality Plan, ensuring alignment with the scope of assignment. Responsibilities include assisting staff in improving compliance with ICH, GCP, SOPs, KPIs, applicable regulatory requirements, and guidelines, while providing advice and support on quality control, risk management, and corrective/preventive actions.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks, conduct site assessments, and manage CAPAs.
• Support inspections and audits while serving as the local GCP expert.
• Drive inspection readiness and compliance at the country level.
• Adopt and implement the global Quality Management Plan within the scope of the assignment, including:
  • Planning and executing Quality Management activities.
  • Risk identification and assessment through data review and quality control processes.
  • Providing support in risk mitigation, corrective/preventive actions, and guidance for improvement.
• Collaborate with business lines and stakeholders to maintain focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor-specific Quality Management plan and Risk Management Program, monitoring implementation and delivery.
• Provide advice and support to teams on all aspects of GCP compliance.
• Work with Quality Assurance and business staff to manage non-compliance, quality issues, and support corrective/preventive actions per SOPs.
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues per SOPs.
• Act as the primary contact for Quality Assurance on quality matters at the assignment level, attending meetings/teleconferences.
• Prepare periodic reports to business lines on quality-related matters, risk assessments, and specific quality improvement initiatives.
• Perform other reasonable tasks as required by the role, upon agreement with the line manager.

Qualifications

• 9+ years of total experience.
• Clinical Operations background plus GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred.
• Bachelor’s Degree or equivalent qualification (or equivalent combination of education, training, and experience).
• Sound working knowledge of medical terminology, SOPs, ICH, GCP, applicable regulatory requirements, and quality management processes.
• Knowledge of national and international regulations and drug development processes.
• Knowledge of CRO or pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Strong organizational, interpersonal, and communication skills.
• Good judgment and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills, including Microsoft Office applications.
• Excellent problem-solving skills.
• Ability to travel within the region/country.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients/customers.
• Fluent in English.

Pay

The potential base pay range for this role, when annualized, is $62,800.00 – $216,000.00. The actual base pay offered may vary based on job-related qualifications, location, and/or schedule. Dependent on the position, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.