Vertex · 7 hours ago
Associate Director, Operational Quality Product Launch
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$157K/yr - $235K/yr
8+ years expVertex is a global biotechnology company that invests in scientific innovation, and they are seeking an Associate Director of GMP Operational Quality Assurance. This role is responsible for overseeing multiple new product launches, ensuring alignment with business timelines and compliance with global regulatory requirements while collaborating with internal and external stakeholders to resolve complex quality issues.
Computer Software
Responsibilities
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, MBR 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
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
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
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
Qualification
Required
Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 8 years of work experience and 2 years of management experience, or the equivalent combination of education and experience
Experience providing Quality support and oversight of GMP manufacturing operation at Contract Manufacturing Organizations and Contract Test Laboratories including batch release preferred
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 management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
Demonstrated ability to work independently to provide QA support for large, multifaceted projects
Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action
Ability to independently lead cross-functional teams and represent the Operational Quality unit
Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
Demonstrated adaptability, thinking analytically with ability to conduct data analysis while paying attention to details
Knowledge of applications: Esko-Artwork Management System, OPM (Oracle), MS Office, PowerBI, Veeva
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
Benefits
Medical, dental and vision benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase