Product Quality Complaints Manager

Sumitomo Pharma•Marlborough, MA

3d•Remote

About The Position

The Product Quality Complaints Manager is part of the Quality department and reports to the Senior Director, PV Quality Assurance. The role supports compliant management of product complaints associated with commercial and clinical products, overseeing complaint intake, assessment, investigation, documentation, and closure in accordance with applicable regulatory requirements and company procedures. The position works closely with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance. This is an individual contributor role with no direct reports or formal people-management responsibilities. It is primarily remote, with periodic on-site office meetings, and requires the ability to travel domestically and internationally as needed. The work involves a fast-paced environment, multiple competing demands, independent judgment, and extended personal-computer use.

Requirements

Bachelor’s degree in a related field, or equivalent years of work experience.
At least 4 years of relevant experience in the biotechnology or pharmaceutical industry.
At least 3 years of product complaint experience.
Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities.
Working knowledge of cGMP requirements and quality management systems.
Comprehensive understanding of cGMP requirements and pharmaceutical quality systems.
Strong knowledge of FDA, global GMP, pharmacovigilance, and product-complaint regulations and guidance.
Demonstrated experience managing pharmaceutical, biotechnology, medical-device, and/or combination-product complaint processes.
Excellent investigation, root-cause analysis, problem-solving, and risk-assessment skills.
Experience using electronic quality management systems (eQMS) and complaint-management databases.
Strong written and verbal communication skills, including the ability to communicate effectively across organizational levels.
Ability to prioritize multiple competing activities in a fast-paced, highly regulated environment.
Strong attention to detail and commitment to data integrity and documentation quality.
Ability to work independently and make sound, risk-based decisions using independent judgment.
Ability to exercise appropriate judgment, take initiative, and work independently.
Ability to use a personal computer for extended periods.
Ability to travel domestically and internationally as needed.

Responsibilities

Manage the intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products in accordance with regulations and company procedures.
Receive, evaluate, and process product complaints, including identifying and forwarding potential adverse-event, lack-of-effect, and product-quality reports to appropriate functions.
Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information for complaint evaluations and product-quality assessments.
Ensure complaint records are complete, accurate, fact-based, well-written, and maintained in a state of inspection readiness.
Manage follow-up with consumers, healthcare professionals, pharmacies, distributors, and other external contacts to obtain complaint information and supporting documentation.
Coordinate product sample returns, sample tracking, laboratory testing requests, and related complaint documentation.
Draft and issue complaint response communications as required.
Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.
Review and approve complaint records, investigations, assessments, customer communications, and closure documentation for completeness, accuracy, compliance, and adherence to company procedures.
Use independent judgment to evaluate complaint information, determine investigation requirements, assess product-quality impact, and recommend appropriate disposition and closure activities.
Maintain confidentiality and handle sensitive product-quality and patient information.