Reporting to: Director, Quality Assurance
About This RoleAs 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 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
Who You Are:Working with our fast-paced, growing team, you bring post-marketing Quality expertise to ensure the US complaints program meets the highest standards. With a sharp eye for compliance and detail, you have the ability to manage multiple priorities while remaining consistently focused on patient safety.
Required Skills & Experience:- 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
Preferred Skills:- 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
Additional Information: The base compensation range for this role is $140,000 - $160,000. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
