QA Manager

Reporting to: Director, Quality Assurance

About This Role

As part of the Quality team, you will play a key role in the day-to-day management of product quality complaints, owning the complaints process and training, and supporting the Quality team. In partnership with the US Head of Quality, you will ensure that appropriate complaints processes are in place for the US organization, aligned with the global and local Quality strategy and requirements.

This role is onsite at least four days a week, and candidates must be willing and able to come to our office in Concord, MA.

What You’ll Do

• Day-to-day oversight of product quality complaint activities, including intake, triage, file closure, management of the complaints inbox, vendor performance, training on relevant ITF conventions and SOPs, and responding to issues arising from daily activities • Ensures timely notifications to pharmacovigilance, the NDA/BLA holder, and Quality leadership teams • Coordinates investigations with manufacturing sites and ensures appropriate documentation is included in complaint files • Performs follow-up with reporters and coordinates sample returns • Reviews social and traditional media reports to identify PQCs • Ensures reconciliation of complaints with relevant internal and external partners are completed in a timely manner • Liaises with Medical Information and PV teams • Collaborates with internal stakeholders and partnered vendors to identify and implement improvement areas • Owns…