Product Complaints Quality Manager (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 69.000 - 76.000; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals LLC is seeking a Product Complaint Manager to support the Product Complaint Quality System within the Small Molecule, Biologics, Device CMC Compliance team. You will partner with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, and QA to drive compliant product complaint processes.

Responsibilities include triage, investigation reports, deviations review, CAPA, plus training cross-functional teams and monitoring

Qualifikationen

• Experience in a Quality Assurance role supporting complaint management and CAPA.
• Familiarity with device, biologics or small molecule contexts.
• Understanding of GMP/GDP regulatory expectations.

Aufgaben

• Support product complaint processes including reconciliation, triage and SOP management.
• Process incoming clinical and commercial product complaints and initial evaluation.
• Investigate product complaints and author investigation reports; coordinate external investigations as needed.
• Perform quality review of investigations owned by others and escalate critical issues.
• Assist with trending, metrics, and quarterly reporting; participate in cross-functional reviews.
• Provide training on the product complaint process to cross-functional teams.

Kenntnisse

Quality Assurance

Complaint management

Root cause investigations

CAPA development

GxP knowledge

GMP/GDP regulations

Technical writing

Communication skills

Cross-functional collaboration

Project management

Ausbildung

Master’s degree in a scientific field

Bachelor’s degree in a scientific field

Jobbeschreibung

Job Description

The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at Vertex. This role will support quality activities associated within the Small Molecule, Biologics, Device CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.

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 andtriage
• 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 orallied health field and 8+ years of relevant work experience, or relevant comparable background.
• Must have 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

Contract Length: 12 months with the chance to extend

Pay Range

$50/hr. - $55/hr.

Shift/Hours

Monday - Friday; Hybrid - 3 days onsite

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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