Product Complaints Quality Manager (Contract)

About Vertex Pharmaceuticals Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and has made significant advancements in cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain — and continues to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Our global headquarters is in Boston, and we have research and development (R&D) sites and commercial offices worldwide. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards. Read our community guidelines: https://www.vrtx.com/vertexs-community-guidelines/

Vertex Pharmaceuticals

The Science of Possibility

cystic fibrosisAPOL1-mediated kidney diseasessickle cell diseasebeta thalassemiaDuchenne muscular dystrophytype 1 diabetes mellitusand Pain

V

vrtx.com

5,001-10,000 employees

Biotechnology Research

Boston, MA

1989

Public Company

645k LinkedIn followers

Raised $5.2B

• 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.
• 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.

Required

• 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

• 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
• $50/hr. - $55/hr.
• Monday - Friday; Hybrid - 3 days onsite
• 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
• If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.