Title:
Product Compliant Quality Manager
Location:
Boston - Fan Pier
Pay:$70.00-$75.00
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Job Description
Summary:
The Product Complaint Manager supports the Quality System by overseeing all aspects of product complaint management within the organization’s small molecule, biologics, and device portfolios. This role partners cross-functionally with internal and external stakeholders—including Patient Safety, Supply Chain, Medical Information, Quality Assurance, Contract Manufacturing Organizations, and Call Centers—to ensure timely, compliant, and effective resolution of product complaints.
Key Responsibilities:
- Support product complaint lifecycle activities, including intake, triage, reconciliation, trending, sample management, training, and SOP updates.
- Conduct and document product complaint investigations, coordinating with Contract Manufacturing Organizations for external follow-up as required.
- Perform quality review of complaint investigations completed by other team members to ensure accuracy, completeness, and compliance.
- Compile and analyze complaint metrics and author quarterly trending reports.
- Deliver cross-functional training on complaint processes and participate in related quality system activities, including deviation management and CAPA development.
- Assess and implement changes to procedures based on new regulatory intelligence or quality system improvements.
- Represent the product complaint function in internal and external meetings, audits, and inspections.
Qualifications:
Minimum Requirements:
- Bachelor’s degree in a scientific or allied health field and 8+ years of relevant experience, or a Master’s degree with 3–4 years of relevant experience.
- Proven background in Quality Assurance roles supporting complaint management, root cause analysis, and CAPA in biologics, medical devices, or pharmaceuticals.
Preferred Skills:
- Strong understanding of GMP/GDP and regulatory requirements (21 CFR 820, ISO 13485).
- Experience managing cross-functional projects and complex investigations.
- Excellent technical writing and communication skills.
- Demonstrated analytical, problem-solving, and critical-thinking abilities.
- Ability to thrive in a fast-paced, collaborative environment.
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