Vertex · 9 hours ago
Associate Director, Product Quality (Hybrid)
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$151K/yr - $227K/yr
8+ years expVertex is a global biotechnology company that invests in scientific innovation, and they are seeking an Associate Director of Product Quality. This role is responsible for end-to-end quality oversight of small molecule programs throughout their lifecycle, ensuring alignment with industry and regulatory expectations while collaborating with cross-functional teams to support product development and commercialization efforts.
Computer Software
Responsibilities
Provide clearly defined Quality expectations, Quality strategy, and Quality deliverables for the assigned program(s) within the Vertex product portfolio, including in-licensed and outsourced products, as part of commercialization and product lifecycle management
Develop, approve, and maintain critical Quality standards and control requirements for products and processes (e.g., stage gate deliverables, product specifications, stability program development), working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle and QbD. Ensure quality and compliance frameworks, guidance, and systems are in place to keep them current with general industry and health authority expectations as well as Vertex’s QMS
Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with development functions and supply chain to improve manufacturing processes, new product introduction standards, and overall program strategy and keep them current with global regulatory expectations and internal Vertex standards, integrating the scientific intent of the technical SMEs and clinical phase-appropriate approaches, as applicable
Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing and across all drug product presentations in support of commercialization. Ensure that the identified risks, mitigations, and possible improvements are understood by CMC development team stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission, and launch
During lifecycle management of a product, support post-approval changes due to continuous improvement, regulatory requirements or commitments, geo-expansion strategy, and business driven reasons. Proactively identify Quality risks and product quality issues and support post-approval changes to mitigate these risks by partnering with the commercial manufacturing project teams and stakeholders
Ensure significant Quality risks are escalated per the company procedure and properly mitigated in a timely manner by working with the cross-functional/site teams
Champion a consistent approach to Quality and compliance standards as they relate to product, recognizing the wider implications of Quality-related issues, including the implementation of the principles of Quality by Design and new and emerging regulatory guidance
May serve as a single point of Quality contact for new product introduction and PAI readiness for the assigned product(s) on the CMC product and/or project governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP/GDP clinical trial materials and commercial products to ensure a global Quality strategy is developed and maintained for consistency and standardization (to the extent it is practical)
Represent Quality at appropriate governance meetings to critically review product strategy, promoting a risk-based approach
Act as a project manager within Quality for the assigned project, ensuring and facilitating effective multi-directional communication between the Quality groups and cross-functional teams and ensuring standardized processes (e.g., new product introduction, risk assessments, technology transfers, etc.) are used
Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving relevant documents per team timeline and associated HA questions on the filing. Support device development for combination products (as needed) by taking part in design history file reviews, strategy, risk identification, and risk mitigation
Define resource allocation for network of QA resource assignment for his/her/their assigned products
Qualification
Required
Bachelor's or Master's degree in a Scientific/Technical/Business discipline
Minimum of 8 years of deep and broad experience in a technical, quality, and/or regulatory role within the pharmaceutical/biopharmaceutical industry in product development and associated project management and governance is required
Expertise in cGMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance, quality standards, policies and procedures
Demonstrated application of the principles of cGMP and Quality Assurance
Experience in the practicalities of implementing 21st century cGMP guidelines, ICH Q8/9/10/11, PAT/ASTM guidance, etc
In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies
Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections)
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member
Demonstrated influential leadership experienced in operating in a matrix organization (across boundaries) with Technical, Supply Chain and Regulatory functional areas through presenting, influencing, negotiation and partnering is required
Capable of building alignment across diverse perspectives and functional areas
Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions
Experience in technology transfer, process development and/or process validation
Preferred
Key areas of preferred expertise are: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring
A minimum of 3 years in directly managing staff and/or leadership experience in leading cross-functional teams, projects, programs, or directing allocation of resources is preferred
Previous experience on a Site Leadership Team or R&D Leadership Team is strongly preferred
Benefits
Annual bonus
Annual equity awards
Overtime pay
Medical benefits
Dental benefits
Vision benefits
Generous paid time off
Educational assistance programs
Student loan repayment
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