Senior Quality Assurance Leader
Mantell Associates is a leading pharmaceutical organization seeking an experienced Senior Quality Assurance Specialist to join their talented team.
Responsibilities:
* Oversee the New Product Introduction (NPI) process, ensuring successful clinical and commercial drug product manufacturing for new customers and products.
* Lead the Product Quality Team in disposition of batches, tracking batch release, and partnering with other departments to close out deliverables supporting product disposition.
* Develop and oversee the Quality on the Floor Program, responsible for visual inspection and packaging operations.
* Provide strategic guidance to resolve complex investigations and product quality issues.
* Review and approve Commissioning and Validation protocols and final reports.
* Review and approve QC stability study summaries, protocols, and final reports.
Requirements:
* A scientific degree and strong experience in Quality Assurance leadership within a GMP-related field, preferably in biotechnology, biologics, or pharmaceutical manufacturing.
* GMP compliance knowledge.
* The ability to efficiently prioritize workload across the team.
* A team player with exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and high collaboration abilities with various levels of the organization.
What We Offer:
* A dynamic and collaborative work environment.
* Opportunities for growth and development.
* Competitive compensation and benefits package.