Our client is a biopharmaceutical company founded by renowned scientists, pioneers in modern genomics. The company develops new therapeutics for neurodegenerative diseases - orphan and common – where there are currently no cures and existing therapies available.
The Associate Director of Quality Assurance, Quality Management Systems will report to the Company’s Chief Quality Officer (CQO) and will be responsible for developing, implementing and maintaining robust quality systems and procedures across all activities conducted by the Company with a key focus on GxP areas.
- Administer the Quality Management System in compliance with the Quality strategy
- Develop and coordinate the creation and revision of Quality Documents (SOPs, Business Guidance etc.) in close collaboration with representatives of functional areas
- Manage vendors’ qualification and QA oversight in the different GxP areas
- Organize and/or deliver trainings in area of GxP expertise and associated SOPs
- Lead continuous improvement of the QMS to ensure compliance with evolving regulatory requirements
- Work closely with the Company’s Senior Leadership to drive adoption and implementation of the QMS system and risk management process across the organization
- Scientific background with a higher educational degree in a scientific discipline
- Pharma/biotech industry experience (approx. 10 years) with a minimum of 5 years in Quality Assurance
- Strong knowledge of at least 2 GxP areas (GMP and GCP, or GLP and GMP ect.)
- Experience with the administration of an eQMS software is a plus
This is a fast-paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required.
Ongoing search to fill this position is occurring during the COVID-19 New Jersey Statewide Stay at Home Order and as such, job functions may start out as a work from home position with the intent being that they will transition back to in-office along the same timeline as the rest of the in-office personnel.