Job description

Join our team dedicated to curing rare diseases! We value our team members' growth and well-being as much as our scientific progress. We seek collaborative, hands-on individuals passionate about making a difference for patients. This is an opportunity to be part of a small, dynamic team and contribute to an innovative biotechnology organization.

Position Summary:
Lead the strategic planning and technical operations of the Quality Control Department, supporting clinical and commercial manufacturing of gene therapy products.

Responsibilities:

Lead strategic planning and technical operations of the QC Department.
Represent QC in cross-functional meetings.
Partner with various departments to implement strategies.
Oversee critical investigations and ensure regulatory compliance.
Ensure accuracy and scientific soundness of QC data.
Maintain GMP compliance and optimize laboratory productivity.
Coordinate with external service providers and ensure quality agreements.
Oversee daily QC operations and manage a team.
Set financial goals and manage budgets.

Qualifications:

PhD in Molecular Biology, Cell Biology, Immunology, or related field with 20 years of experience in GMP/QC, or equivalent experience.
Minimum 20 years of leadership experience.
Experience with gene/cell therapy products.
Strong knowledge of GMPs and regulatory requirements.
Experience with method validation and regulatory submissions.
Strong analytical, communication, and problem-solving skills.

Desired Competencies:

Strategic thinker with strong leadership and project management skills.
Ability to interact and motivate across departments.
Manage issues with urgency and ensure continuous improvement.