GMP Operational Quality Packaging & Labeling Validation Associate Director at Vertex Pharmaceuticals in Boston, MA

Job description

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 Validation projects associated with Product Launch and Continuous Improvements, 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 project execution for Finished Goods (FG) commercialized globally. The role is responsible for coordinating and/or or executing Validation activities on multiple complex projects and ensures process robustness from initial design through ongoing product supply and continuous improvements. This position reports directly to the Director of GMP Operational Quality. Key Responsibilities: The responsibilities of this position may include, but are not limited to, the following: Responsible for FG Validation of commercial products in all global regions for the GMP Operational Quality organization. Standardize Validation processes to ensure compliance and consistency across programs. Manage Validation commercialization oversight for operating teams through technical transfer, validation, MBR creation, launch support and process improvements through product/process life-cycle management. 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 Establish Quality-by-Design (QbD) principles for primary, secondary and FG Packaging and Labeling. Provide strategic quality oversight to operations at external manufacturing sites in alignment with the Vertex corporate Quality strategy Develop framework for ongoing QbD efforts Establish Critical Process Parameters (CPPs) for relevant manufacturing process. Establish Continuous Process Verification (CPV) measures to evaluate manufacturing process health. Create KPIs and Metrics to evaluate Validation process analytical data to emphasize process reliability and effectiveness. Oversee OOS, OOT and Trending for primary, secondary and FG manufacturing operations. 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 –for FG Quality Management System of Global Commercial Finished Goods Define and optimize Validation 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 Establish Continuous Improvement framework for Validation and continued 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 Minimum qualification