Associate Director, Development Asset Quality
hace 7 días
About the Role
We are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante empresa. As a key member of our Development Quality Team, you will play a critical role in driving Quality Culture with Development, Regulatory, and Safety stakeholders.
Key Responsibilities
- Develop and execute a comprehensive quality strategy to ensure the delivery of high-quality development assets.
- Manage business relationships with key stakeholders, including senior leaders in Development, Regulatory, and Safety.
- Lead the development and delivery of GCP risk-based robust quality management activities.
- Manage Associate Directors/study quality leads, providing mentoring and coaching.
- Assist in the development of an overarching strategy related to proactive and sustainable quality and compliance for assigned Therapeutic Area(s) (TAs).
- Represent DAQ on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to identify critical to quality risks and mitigation strategies.
- Work with cross-functional and other quality partners to identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develop mechanisms for detection, oversight, and trending.
- Serve as the quality expert for global/systemic clinical quality issue investigations.
- Perform Quality Event risk assessments and trending to determine robust CAPAs.
- Act as quality approver for Quality Issues and CAPAs as assigned.
- Lead inspection readiness for assigned programs/portfolio, promoting a culture of inspection readiness and sustainable clinical compliance.
- Provide guidance to team members in Inspection Readiness and Preparation Activities.
- Support follow-up and tracking of inspection commitments and effectiveness checks for assigned programs/Therapeutic Area.
- Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements.
- Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities.
- Actively participate in meetings driving quality and business performance.
- Support Due Diligence and integration activities as assigned.
Requirements
- Bachelor's degree in life science or equivalent field, required.
- Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.
- Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA, etc.).
- 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.
- Experience with multinational products and regulations as well as with mandated risk management plans.
- Ability to travel up to 10%.
Preferred Qualifications
- Advanced degree preferred.
Competencies to be successful for this position include:
- Quality, process, and compliance oriented.
- Strong interpersonal skills.
- Critical thinking.
- Integrity.
- Communication.
- Teamwork.
- Problem solving.
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