Product Complaint Manager — QA & Regulatory Compliance

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 97,000 - 107,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking a Product Complaint Manager based in Lexington, MA. This role supports compliance by ensuring thorough handling of product complaints associated with both marketed and investigational products.

The ideal candidate should have a Bachelor’s in a scientific field and 5+ years of experience in GMP environments. Responsibilities include managing complaints, leading investigations, and collaborating cross-departmentally.

The position offers a competitive pay range of $97,000 - $107,000 and fosters a patient-first culture.

Qualifications

• 5+ years’ experience in a GMP biopharmaceutical setting.
• Familiarity with GMP regulations and ICH guidelines.
• Experience in leading product complaint investigations.

Responsibilities

• Manage product complaint processes to ensure compliance.
• Conduct thorough investigations and document findings.
• Collaborate with various departments for complaint resolution.

Skills

GMP biopharmaceutical experience

Strong written and verbal communication skills

Detail-oriented

Proactive mindset for continuous improvement

Education

Bachelor of Science degree in a scientific field

Tools

Excel

Word

PowerPoint

Veeva (electronic document management system)

Job description

Kiniksa Pharmaceuticals is seeking a Product Complaint Manager based in Lexington, MA. This role supports compliance by ensuring thorough handling of product complaints associated with both marketed and investigational products.

The ideal candidate should have a Bachelor’s in a scientific field and 5+ years of experience in GMP environments. Responsibilities include managing complaints, leading investigations, and collaborating cross-departmentally.

The position offers a competitive pay range of $97,000 - $107,000 and fosters a patient-first culture.