Responsibilities:
- Lead client and partner quality management activities, ensuring alignment with licensing agreements, contracts, and quality agreements.
- Manage the client notification process.
- Oversee resolution of client quality events, including deviations, change controls, CAPAs, and investigations.
- Oversee and support quality and Alliance/program/project management with transfer of quality deliverables (e.g., batch release, document approvals, and other documentation).
- Develop and maintain strong client relationships to enhance transparency and collaboration.
- Partner with and represent Quality at internal cross-functional meetings to support client management.
Requirements:
- Bachelorβs degree in the life sciences fields or equivalent work experience.
- 7 years of experience in pharmaceutical or other related regulated industry.
- Strong understanding of GxPs (including GMP, GDP, GLP, and GCP), global regulatory expectations, and pharmaceutical quality systems.
- Demonstrated client collaboration experience.
- Strong communication, negotiation, and problem-solving skills.
Preferred:
- Advanced degree.
- Quality experience within a regulated industry.
- Demonstrated leadership and project management abilities.
Benefits:
- Competitive salaries and an excellent benefit package.
Application instructions:
- All applicants must have authorization to work in the US for a company.