Manager, Quality Assurance

ITF Therapeutics•Concord, MA

9d•$140,000 - $160,000•Onsite

About The Position

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.

Requirements

5+ years of relevant and progressive experience in Quality or Product Quality Complaints in the biotech and/or pharmaceutical industry
Strong foundation with FDA and progressive experience with international regulations

Nice To Haves

Bachelor’s degree in a STEM field
Experience working with US FDA and international regulatory bodies, including EMA or MHRA
Proven track record working in a high-paced, globally matrixed environment
Readiness to initiate and lead department initiatives
Clear and strategic communication skills to engage Quality leadership, key stakeholders, and external partners to drive alignment and organizational objectives

Responsibilities

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 the PQC process, including developing and maturing related processes and procedures to ensure product quality and patient safety
Presents PQCs during audits and inspections, and owns responses and mitigation
Generates and presents complaint trends and performance indicators to ensure trends are identified and escalated, and the PQC process is robust and efficient
Leads the coordination and oversight of PQC Awareness training for internal staff and applicable vendors/partners, utilizing the learning management system and providing live training when required to support compliance
Manages vendor relationships and related documents
Proactively partners with legal, purchasing, commercial teams, and other relevant stakeholders to review and ensure appropriate PQC language is incorporated into contracts and purchase orders with applicable vendors and third parties