Director, Commercial Quality-Packaging and Labeling

Vertex Inc.•Boston, MA

2d•$184,600 - $277,000•Hybrid

About The Position

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.

Requirements

Strong leadership capability with demonstrated success leading through managers and senior professionals in a complex GMP environment
Proven ability to convert strategy into operational execution plans and to sustain delivery through clear governance, priorities, and accountability
Strong knowledge of global GMP/GDP requirements and commercial packaging and labeling operations in a pharmaceutical environment
Demonstrated experience applying risk-based quality principles to operational decisions, escalation management, and release-related activities
Strong working knowledge of packaging and labeling requirements across the US, EU, and rest of world markets
Demonstrated ability to lead cross-functional teams and influence internal and external stakeholders without direct authority
Strong communication, facilitation, and decision-making skills, with the ability to align teams around clear actions and priorities
Experience developing quality metrics, monitoring operational performance, and driving process improvement
Strong ability to identify organizational gaps, clarify decision ownership, and strengthen operating discipline across multiple levels of the organization
Experience with Operational Excellence tools and methods, including Root Cause Analysis and continuous improvement approaches
Strong judgment, attention to detail, and ability to balance compliance, business continuity, and execution pace
Bachelor’s degree in a scientific or allied health field, or equivalent degree
Requires 10+ years of relevant work experience and 4+ years of management experience, or the equivalent combination of education and experience

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
Seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

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