Director/Senior Director of GMP Quality Assurance
Concord, MA or Remote
The candidate will work with cross-functional employees, consultants, and external partners in outsourced development, manufacturing, and global supply-chain environments.
The Director/Senior Director should have experience with outsourced drug substance development and manufacturing; oral and injectable drug product development and manufacturing; analytical testing; and packaging, labeling, and distribution of clinical and commercial supplies. In addition, the candidate should be knowledgeable of FDA, EMA, and ICH regulations and quality guidelines. The ideal candidate will also have experience in the development, implementation, and management of GxP quality management systems.
The Director/Senior Director will report to the Senior Vice President of Technical Operations. This position can be located remotely. Travel to the Tremeau home office in Concord, MA and to GMP manufacturers will be required at specific times when the global COVID-19 pandemic no longer requires travel or in-office restrictions.
Key Responsibilities
- Oversee GMP compliance for all investigational programs. Build the company’s GMP quality management systems for late-stage investigational and future commercial programs.
- Formulate the company’s GMP compliance and process validation strategies based on FDA, EMA, and ICH regulations and guidelines and on current industry approaches.
- Chair the Quality Management Steering Committee.
- Provide leadership and direction for the development and implementation of GxP processes and procedures.
- Lead commercial and inspection readiness preparations internally and at GMP vendors.
- Oversee documentation and training programs for all GxP employees and consultants.
- Oversee GMP Quality Operations activities for the release of Drug Substance, Drug Product, and Finished Goods for projects in all phases of clinical development and commercial.
- Oversee release and stability testing; method validation and transfers; specifications; and reference standard qualification conducted at GMP vendors.
- Oversee all GMP events (deviations, investigations, change controls, and CAPA’s). Lead or participate in Quality Risk Assessments.
- Lead and manage quality compliance with external vendor partners, oversee execution of GMP audit program, write or review reports, and track corrective actions.
- Establish internal quality and vendor performance metrics. Lead continuous improvement initiatives.
- Develop budgets and manage resources to meet department and company objectives.
- Review regulatory filings.
Requirements
Tremeau offers a competitive salary and benefits package. To apply, please fill out the information below or send your resume to careers@tremeau.com and include the job title in the subject line. No recruiters please.
