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Product Complaints Quality Manager
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Job Description
The Product Complaint Manager is responsible for supporting the Product Complaint Quality System. 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 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 andmedical 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
Pay ranges between $70-75/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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