Manager, GMP Operational Quality Packaging and Labeling (Hybrid)

Job Description

GENERAL/POSITION SUMMARY

The Quality Manager is responsible for managing multiple department activities with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in the Packaging and Labeling function. The Quality Manager is adept at troubleshooting problems, coordinating and executing activities on multiple complex projects, ensuring alignment with corporate goals and compliance with all regulatory requirements. The Quality Manager is responsible for oversight of CMOs and disposition activities for packaged commercial material and ensuring appropriate Change Management within their purview. This role is expected to work closely with internal and external business partners and stakeholders to ensure continuation of supply in all markets.

This position reports to Associate Director.

Key Duties & Responsibilities

The responsibilities of this position may include, but are not limited to, the following:

• Develop relationships with strategic external partners (i.e., CMOs) in support of Vertex’s expanding commercial portfolio and manage ongoing relationships.
• Responsible for disposition activities for Finished Goods Commercial Product, including:
  • Review of Executed Batch Records (EBRs) for commercial packaging operations verify compliance of material for relevant region(s)
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
• Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified. Triage incoming events and escalate through Escalation process and prepare for MRB, as needed.
• Serve as QA assessor/approver on Commercial Change Controls: resolve gaps, approve change plans, verify change classifications, provide strategy for GMP release and disposition strategy
• Provide quality support for continuous improvement of Artwork version control, Bill of Materials and change management.
• Support the GMP Management Review process; review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; recommend mitigation approaches.
• Assist with creating and maintaining Quality Agreements and ensuring CMO compliance to Quality Agreements
• Facilitate QP declaration requests, updates to filings and QP Release supporting documentation.
• Provide compliance guidance to Commercial project teams
• Provide Audit / Inspection support with preparation activities, as SME responder and with post audit/inspection responses

Education and Experience

• B.S in scientific or allied health field
• Typically requires 4 years of experience or the equivalent combination of education and experience

Required Knowledge/Skills

• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing drug products and knowledge of oral drug product manufacturing practices
  • GMP regulations and application to Manufacturing and Testing risk management principles
  • Previous experience in Commercial Packaging and Labeling
  • Root Cause Analysis tools/methodology
• Leadership skills with the ability to thrive in a high throughput environment
• Attention to detail
• Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Project Management / Continuous Improvement
• Ability to lead and manage projects/teams within department objectives and project timelines
• Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
  • Demonstrated ability to work independently to provide QA support for large, multifaceted projects
• Collaboration / Teamwork / Conflict Management
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Ability to understand and translate business needs
• Flexibility/Adaptability
• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • GMP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology
• Sense of urgency - ability to act quickly/escalation process/transparency

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.