Sr. Specialist , GCP/GLP/GVP Quality Assurance
This role is an exciting opportunity to be a part of the Quality Assurance organization. We are looking for a dedicated resource that can contribute to our transition from an early clinical phase Biotechnology company to a company that will support late phase clinical trials.
Reporting to the Sr. Director of GCP/GLP/GVP Quality Assurance, located at the our Headquarters in Cambridge, MA, the Sr. Specialist of GCP/GLP/GVP Quality Assurance, will (i) be a key contributor to, and be responsible for helping to establish and sustain the Quality Management System for the areas of GCP, GLP and GVP, (ii) be a key contributor and support the systems of clinical Corrective Actions/Preventive Actions (CAPAs) and Clinical Issues, and other quality systems for ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). The appointee will also be responsible to partner with clinical study teams and other Clinical Development functions, as necessary, to create a quality culture within our company and help reach a sustained state of inspection readiness.
location: Cambridge, Massachusetts
job type: Permanent
salary: $115,000 - 1,250,000 per year
work hours: 9 to 5
- Assist in improving overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations.
- Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.
- Manage the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.
- Manage the issuance of audit reports and the tracking/monitoring of corrective responses to audit findings to completion.
- Participate in internal audit program and third party/regulatory inspection programs for the Cambridge facility.
- BS/BA, with a minimum 5-8 years Quality Assurance experience in Biotech, Pharma or Clinical Research Organization.
- Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and/or GLP regulations.
- Experience working with CROs, vendors, and relationship management preferred.
- Experience managing essential documentation (GCP/GLP/GVP: Policies, SOPs, JDs, Training Records, CVs, etc.) working to good documentation practices.
- Familiarity with common Safety databases (e.g. ArisG, Argus) preferred.
- Excellent clinical/non-clinical judgment and ability to communicate complex clinical/non-clinical issues in a scientifically sound and understandable way.
- Excellent communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
skills: FDA, CAPA, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.