Vertex Pharmaceuticals, Inc Boston , MA 02298
Posted 4 weeks ago
Job Description
General Summary:
The Associate Director, Small Molecule CMC Compliance (Product Complaints and Recalls) is responsible for leading activities associated with the Product Complaint Quality System and Global Recall and Defect Notification Systems. This role will support quality activities associated with the Small Molecule 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 Duties and Responsibilities:
Responsible for all activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, and SOP management, etc.
Supports all activities associated with the global recall and defect notification processes, including mock recalls, SOP management, evaluation of regulatory intelligence and health of the systems.
Directly manages Suspect Product and Counterfeit investigations and oversees the corresponding processes.
Processes incoming clinical and commercial product complaints, including intake, initial evaluation and triage
Leads product complaint investigations, coordinates with CMOs for external investigations, performs Root Cause Analysis, identifies Corrective Actions and escalates critical issues to senior management
Develops quarterly product complaint trend reports, initiates trend investigations and evaluates metrics/KPIs to assess quality impact and adverse trends
Coordinates activities associated with Counterfeit/Suspect product investigations and evaluates third-party investigation reports for potential threats / required escalation
Compiles data and drafts applicable sections of the Annual Product Review (APR)
Conducts quarterly Quality Management Review (QMR) meetings for Product Complaints
Provides training to cross functional teams on the product complaint process and supports training and knowledge management regarding the recall and defect notification processes
Supports global regulatory inspections and inspection readiness activities
Supports quality activities, including deviation and SOP review, QA to GPS business meetings for activities associated with AE/PC reporting, and other activities as needed
Participates in Regulatory Surveillance activities as an SME and evaluates new regulatory intelligence to update processes/procedures as necessary
Provide SME support and guidance associated with VeeQMS activities
Identify areas of improvement and participate in process improvement initiatives
Support of Data, Technology and Engineering (DTE) projects related to implementation of new platforms supporting PCs
Knowledge and Skills:
Demonstrated working knowledge and application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) including US and international/global regulatory requirements and associated guidance's and standards
Strong working knowledge of:
Risk Management
Event/Quality Issue Management process and requirements, including CAPA and Effectiveness Checks;
Root Cause Analysis and Investigation process tools and techniques;
Inspection Readiness
Strong oral and written communication and interpersonal skills
Project Management, Planning and Prioritization skills
Strong technical writing, presentation and communication skills
Strong technical writing, presentation and communication skills
Adaptability / flexibility and ability to work in a fast-paced environment and act with urgency
Strategic "big picture" thinking while maintaining ability to execute at a tactical level / attention to detail.
Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making
Experience advising, coaching or mentoring junior staff Strong understanding of industry standards and best practices
Proven ability to collaborate with cross-functional teams
Education and Experience:
We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:
1.On-Site and work 5 days per week with ad hoc flexibility;
2.Hybrid and work remotely up to two days per week on regularly scheduled days; or select
#LI-AR1 #LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Vertex Pharmaceuticals, Inc