Product Complaints Quality Manager Boston, MA - Onsite

Product Complaints Quality Manager

Boston, MA - Onsite

24 Months

Phone + Zoom

JD :

MUST SUBMIT WITH THE FOLLOWING INFORMATION, or the candidate will NOT be considered;

• Valid LinkedIn Profile
• (3) references from past managers with VALID company email and contact #
• PHOTO ID
• Education verification

MUST HAVE'S - SKILLS;

Background in small molecule and / or medical devices

Experience with post-marketing surveillance

Familiarity with Veeva, TrackWise, and testing labs

Strong understanding of GMP / GDP and CAPA processes

Key Responsibilities :

Support activities associated with the product complaint process , including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.

Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage

Conduct product complaint investigations and author investigation reports. Coordinate with CMOs as needed for external investigations.

General Position Summary :

The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client site in Boston, MA..

Key Responsibilities :

Support activities associated with the product complaint process , including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.

Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage

Conduct product complaint investigations and author investigation reports. Coordinate with CMOs as needed for external investigations.

Perform quality review of complaint investigations owned / authored by other members of the team.

Escalate critical issues to senior management.

Assist with the PC trending process, including metrics computation and quarterly report authoring.

Provide training to cross functional teams on the product complaint process.

Support quality activities associated with product complaints, including deviation and SOP review, representing the team as necessary at cross functional meetings, etc.

Evaluate new regulatory intelligence related to the PC system and update processes / procedures as necessary.

Identify areas of improvement and participate in process improvement initiatives.

Minimum Qualifications :

Master's degree and 3-4 years of relevant work experience, or Bachelor's degree in a scientific or allied health field and 8+ years of relevant work experience, or relevant comparable background.

Must have extensive experience in a Quality Assurance role supporting complaint management and root cause investigations / CAPA development in at least one of the following areas : device, biologics or small molecule.

Preferred Qualifications :

Understanding of industry standards and best practices

Proven ability to manage projects of significant scope and complexity, while meeting deliverable timelines.

Excellent technical writing, presentation, and communication skills.

Broad GxP Knowledge and understanding across lifecycle of the product

Knowledge and application of GMP / GDP regulations and application to product complaints and medical devices.

Strong collaboration skills with the ability to thrive in a fast-paced environment

Critical, Analytical and Strategic thinking skills

Investigation, Root Cause and CAPA experience

Vivek Kumar

Lead Technical Recruiter

Contact No : +1 646 968 8493

vivek@stellentit.com