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, ensure compliance with ICH, GCP, SOPs, KPIs, applicable regulatory requirements, and guidelines. The role provides advice and support to clinical staff and key stakeholders 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.
• Perform risk identification and assessment through data review and quality control processes.
• Provide support in risk mitigation, planning corrective/preventive actions, and guidance for improvement.
• Support assigned business line management and staff to enhance effectiveness.
• Cooperate closely with relevant business 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, and monitor implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of GCP compliance.
• Work closely with Quality Assurance and assigned business staff to manage non-compliance and quality issues, and support planning of corrective/preventive actions according to SOPs.
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Act as the primary contact for Quality Assurance on quality matters at the assignment level, attend meetings/teleconferences, and prepare periodic reports on quality-related matters, risk assessments, and specific quality improvement initiatives.
• Assist during audits and regulatory inspections as required by applicable SOPs and agreed with business lines.
• 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; equivalent combination of education, training, and experience accepted.
• 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 Clinical Research Organization (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.