The posting
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 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
EDUCATION AND EXPERIENCE:
- 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
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We 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.
Pay Range:
$184,600 - $277,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
