Associate Director, Operational Quality Product Launch

Job Description

The Associate Director of GMP Operational Quality Assurance is an advanced technical resource and is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The Associate Director of Quality Assurance is responsible for oversight of multiple new product launches, ensuring effective alignment with business timelines and compliance with relevant global regulatory requirements.

This role is expected to work closely with business partners and stakeholders to ensure successful market launch and expansion of existing brands in markets globally. The role is responsible for coordinating and/or executing activities on multiple complex projects and takes a role in the design and execution of new projects. This position reports directly to the Director of GMP Operational Quality.

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

• Responsible for commercial launch process oversight in all global regions for the GMP Operational Quality organization.
  • Standardize launch processes to ensure compliance and consistency across programs.
  • Manage commercial launch oversight for operating teams through technical transfer, validation, M  creation, launch execution and process improvements through lesson learned.
  • Partner with internal Vertex operational stakeholders to establish primary/secondary packaging Validation 'best practices' to support growing business and complexities.
• 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.
  • Support Quality Escalation Lead (QEL), Escalation Action Committee (EAC) and Material Review Board (MRB) discussion, as required.
• Support lifecycle management major events and/or changes for finished goods GMP operations.
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy
• External QP Relationship and Release.
  • Provide strategic quality oversight to operations at external manufacturing sites in alignment with the Vertex corporate Quality strategy
  • Facilitate establishment of QP Release of finished goods for each launch project, inclusive of QP Declaration requests as needed
  • Incorporate QP expectations into quality systems
• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions and reduce risk of potential supply disruptions.
• Establishment of Quality Processes/Process Ownership - Product Launch Quality Management System of Global Commercial Finished Goods.
  • Define and optimize launch work process
  • Serve as training owner and SME for their process
  • Serve as document owner for cross-GxP process
  • Serve as review/approver or owner of deviations
  • Monitor and trend events and identifies/proposes corrective actions
  • May serve as CAPA owner
  • Identify risks and communicate gaps to Quality System owner
  • Create process related metrics/monitors for handoff to lifecycle management
• Quality Agreement Oversight Program:
  Assist with creating, negotiating, maintaining and monitoring adherence to Quality Agreements throughout the launch process
• Establish Continuous Improvement framework for New Product Introductions / Commercial Product Launches for all global regions;
  Lead or participate in process improvement initiatives
• Serve as SME Responder or assist in providing front / back-room inspection support;
  Assists in preparation of audit responses

• Experience providing Quality support and oversight of GMP manufacturing operation at Contract Manufacturing Organizations and Contract Test Laboratories including batch release preferred;
  Previous experience and success navigating gray areas and compliantly leading cross functional teams through complex issues;
  Ability to negotiate and collaborate with team members to achieve results
• In depth knowledge of cGMP and GDP requirements governing oral drug product manufacturing practices
• Experience with primary and secondary packaging (oral solid dosage forms preferred) development and operations with proficient knowledge in a pharmaceutical setting.
• Experience in Facilitation/ Problem Solving /Organization/Coordination and planning/Project Management etc./Root Cause Analysis tools/methodology/technical writing
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
• Experience in conducting / hosting / participating in regulatory / vendor or internal audits
• Project Management / Continuous Improvement

• In-depth experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project…