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Associate Director, Quality Product Complaints / Recalls

Semma Therapeutics

Semma Therapeutics

Product, Quality Assurance
Boston, MA, USA
Posted on Thursday, January 25, 2024

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:

  • Bachelor's degree in relevant field is required.
  • 8 years of experience or equivalent combination of 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