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Associate Director, Development Asset Quality Lead
hace 2 meses
We are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante Empresa. This is a key leadership position that will drive quality culture and excellence in our clinical development programs.
Key Responsibilities- Develop and implement quality strategies to ensure compliance with regulatory requirements and industry standards.
- Lead quality assurance activities, including risk assessments, audits, and inspections, to identify and mitigate potential quality issues.
- Collaborate with cross-functional teams to develop and implement quality management systems and processes.
- Provide guidance and support to team members on quality-related matters and ensure compliance with company policies and procedures.
- Develop and maintain relationships with key stakeholders, including regulatory agencies, vendors, and partners.
- Stay up-to-date with industry trends, regulatory requirements, and best practices in quality management.
- Bachelor's degree in a life science or equivalent field.
- Minimum of 8+ years of experience in clinical research, quality assurance, or a related field.
- Established knowledge of GxP/GCP regulations and guidelines.
- Significant experience with GxP investigations, risk assessments, and CAPA management.
- Experience participating in regulatory inspections.
- Functional planning experience and ability to develop functional vision, priorities, and tactics.
- Ability to travel up to 10%.
- Advanced degree in a life science or equivalent field.
- Experience with multinational products and regulations.
- Experience with mandated risk management plans.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application.
