Senior Director, IDMO Site Quality

About the role

The Senior Director, IDMO Site Quality will oversee all aspects of site quality management for a leading pharmaceutical company. This individual will be responsible for ensuring compliance with regulatory standards and implementing robust quality systems.

Responsibilities

• Oversee the implementation and maintenance of quality systems across multiple sites.
• Ensure adherence to regulatory guidelines and industry best practices.
• Develop and maintain strong relationships with regulatory agencies and external auditors.
• Lead cross-functional teams to address quality issues and improve processes.
• Conduct regular audits and assessments to ensure ongoing compliance.
• Develop and implement training programs for site personnel.
• Manage the site quality budget and resource allocation.

Requirements

• Ph.D. in a relevant field (e.g., Biomedical Engineering, Chemistry, Pharmaceutical Sciences) or equivalent experience.
• At least 15 years of experience in pharmaceutical quality assurance, including leadership roles.
• Proven track record of successfully managing quality systems in a regulated environment.
• Experience with FDA and EMA regulations.
• Strong leadership skills and ability to manage complex projects.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Qualifications

• Knowledge of Good Manufacturing Practices (GMP).
• Experience with quality system documentation and auditing.
• Understanding of regulatory requirements and their impact on site operations.
• Experience with Six Sigma or other quality improvement methodologies.
• Ability to work independently and manage multiple priorities.

Skills

• Strategic thinking and problem-solving skills.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to lead and motivate a diverse team.
• Experience with data analysis and reporting.

Benefits

• Competitive salary commensurate with experience.
• Health insurance coverage.
• Flexible work schedule.
• Professional development opportunities.
• Employee assistance program.

Pay

Commensurate with experience.

Schedule

Full-time, On-site.