Director, Commercial Quality-Packaging and Labeling

Location: Northern

## Director, Commercial Quality-Packaging and Labeling Apply:
Boston, MA:
Full time:
Posted Today:
REQ-30328
** Job Description
**** GENERAL

SUMMARY:

** The Quality Operations Director provides operational leadership for commercial resupply and lifecycle management of primary and secondary packaging and labeling across a global CMO network. The role translates strategy, capacity plans, and business priorities into an efficient operating model across global CMO portfolios.

The Director leads a risk-based quality oversight structure required to assure compliant, reliable, and uninterrupted commercial supply. The role leads a high-performing organization and serves as a senior Quality partner to CMO leadership, Vertex Sr Director of quality operations, Manufacturing &technical operations, Supply Chain, Regulatory, Launch/Technical Quality, and other internal and external stakeholders.
** KEY

DUTIES AND RESPONSIBILITIES:

** The responsibilities of this position will include, but are not limited to, the following:
* Lead operational quality oversight for commercial resupply and lifecycle management of finished goods primary and secondary packaging and labeling activities across US and UK/EU CMOs.
* Translate departmental strategy and business priorities into operational quality plans, resource priorities, and execution expectations for the packaging and labeling quality team
* Proactively build team capability, an inclusive environment and drive consistent team execution. Provide direct leadership for people managers and/or senior staff, demonstrating understanding of team strengths and development areas and leveraging expertise effectively through performance management, talent development, coaching, and succession planning.
* Lead prioritization, decision-making, and coordination across packaging and labeling operational quality activities so that issues are managed at the appropriate level and business results are delivered across the organization
* Act as the primary escalation leader for significant packaging and labeling operational quality issues, ensuring timely triage, risk assessment, communication, and appropriate resolution
* Lead cross-functional operational forums related to commercial resupply and lifecycle packaging and labeling quality, ensuring clear accountability, decision tracking, follow-through, and alignment across internal stakeholders and CMO partners
* Ensure robust procedural oversight of exemption management, QP-related activities, artwork and packaging process change controls, and batch documentation review within the scope of the function
* Ensure robust procedural oversight for disposition of commercial primary and secondary packaged goods, CMO oversight and QTA compliance monitoring,  including risk-based assessment of changes, investigations, jurisdictional limitations and quality events that may affect release or supply status
* Ensure quality processes for commercial resupply and lifecycle packaging and labeling operations are maintained and continuously improved to support compliance, efficiency, business continuity, and risk mitigation across all commercial SM and bio/combo device modalities and product lines.
* Monitor, and trend operational quality metrics and KPIs; ensure metrics identify emerging risks, support management review; ensure team is prepared to collate executive slide presentations for each level of quality governance and leadership review (APQR, Ops Review, QMR, GPLB etc.)
* Build and maintain effective working relationships with CMO Leadership, Qualified Persons, and other external partner leadership to support compliant and reliable commercial operations partnership
* Ensure robust resupply quality input to operational deviation/investigation RCA, CAPA, efficacy checks, product impact assessments, and process support for product complaint investigations related to pack and label operations.
* Ensure inspection and audit readiness within the function and provide leadership support for inspections, responses, and follow-up actions as needed
* Partner with senior Vertex QA leadership on organization design, operating model effectiveness, and capability-building needs across the packaging and labeling quality organization
* Drive clarity of roles, responsibilities, and decision rights across the team to enable appropriate ownership at all levels within the resupply unit as well as across partner interfaces
** KNOWLEDGE AND

SKILLS:

*** Strong leadership capability with demonstrated success leading…