Senior Manager, Development Country Quality

Alexion Pharmaceuticals, Inc.; Ataşehir; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Development Country Quality to ensure compliance and quality in clinical operations. This role involves providing quality-focused guidance and support to clinical trials, fostering a culture of data-driven oversight. You will work closely with local teams to enhance regulatory compliance and implement quality control activities, while also participating in audits and inspections. If you have a strong background in clinical research and a passion for quality assurance, this is a fantastic opportunity to make a significant impact in the field.

Qualifications

• 5-8 years of experience in clinical research with a focus on GCP compliance.
• Good knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA).

Responsibilities

• Support quality and compliance strategies across all programs at the country level.
• Develop and implement local procedural documents for clinical trials.

Skills

GCP compliance

Quality assurance

Risk management

Clinical research

Interpersonal skills

Critical thinking

Problem-solving

Education

Bachelor’s degree in life sciences

Advanced degree (preferred)

Job description

Senior Manager, Development Country Quality

This is what you will do:

• Under the direction of the Director/Associate Director of Development Country Quality, the Senior Manager of Development Country Quality (DCQ) is accountable for Clinical Operations Management (COM) quality support and is responsible for fostering a culture of data- and risk-driven quality oversight of clinical trials. The role involves providing quality-focused guidance for the execution of the Rare Disease Business Unit at the country and site levels.
• The Senior Manager DCQ may actively engage with the Country Operations Team to support sustainable regulatory compliance at the country and site levels via risk-based quality management principles within and across portfolios. Responsibilities include proactive process efficiency assessments and building remediation/optimization in partnership with business process owners and the COM organization.
• This role acts as a clinical compliance advisor/partner to the COM team, working closely with Study DAQs to proactively identify country-level Key Quality Indicators (KQIs) and develop mechanisms for oversight and trending.
• The Senior Manager DCQ collaborates with Study Quality DAQs and risk/issue owners to ensure systemic risks and issues are communicated timely for management and resolution.

You will be responsible for:

• Supporting the execution of overarching strategies related to proactive and sustainable quality and compliance across all programs and therapeutic areas at the country level, in alignment with the (Associate) Director of Development Country Quality.
• Providing quality advice to the Clinical Operations Management (COM) group globally, focusing on GCP compliance and continuous process improvements.
• Developing, implementing, and reviewing local procedural documents, maintaining current knowledge of local regulations and industry practices related to clinical trials.
• Advising local study teams on procedural frameworks, including global clinical processes, procedural documents, and applicable guidelines such as ICH-GCP and local regulations.
• Supporting local management in planning and conducting quality control activities, including site visits, and maintaining the annual quality plan.
• Working with the COM team and other quality partners to identify and develop oversight mechanisms for country-level KQIs, and providing updates on quality issues and trends.
• Collaborating with other quality representatives and supporting local study teams to resolve quality and compliance issues.
• Participating in the preparation for audits and regulatory inspections, and providing feedback and lessons learned from these activities.
• Identifying and resolving potential risks based on QC results, audit and inspection findings, and routine quality management work.
• Supporting the organization of ongoing and ad hoc training for local staff, including onboarding and addressing recurring quality issues.

You will need to have:

• Bachelor’s degree in life sciences or a related field.
• 5-8 years of experience in clinical research, including GCP quality assurance and compliance.
• Good knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA, etc.).
• Experience with GxP investigations, risk assessments, and CAPA management.
• Experience participating in regulatory inspections.
• Experience with multinational products and regulations, including risk management plans.
• Ability to travel up to 20%.

Preferred qualifications:

• Advanced degree.
• Competencies including quality orientation, strong interpersonal skills, critical thinking, integrity, communication, teamwork, and problem-solving.