Vertex · 1 month ago
Associate Director, GMP Operational Quality (Hybrid)
Boston, MA
Full-time
Hybrid
Senior Level
$152K/yr - $228K/yr
5+ years expVertex is a global biotechnology company that invests in scientific innovation. The Associate Director is responsible for oversight and coordination of GMP activities to ensure compliance with regulatory requirements and corporate goals, while managing personnel and supporting departmental activities.
Computer Software
Responsibilities
Responsible for oversight of analytical activities in support of release of commercial products
Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions in support of Analytical QA function
Represents Analytical QA function at meetings with CMO/CTL/Suppliers. Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex. Supports inspection readiness and vendor management teams as needed
Guides and conducts quality investigations, OOS/OOT investigations, deviations. Communicate any risks and gaps to management as known
Reviews investigation reports and corrective action plans for adequacy and compliance. This includes escalation assessment, root cause analysis and product impact assessments for investigations resulting from deviations and OOS. May serve as an Escalation Lead
Ensures appropriate CAPA actions are identified/evaluated and approves investigations/CAPA plans/actions
Assesses and approves Change Controls
May generate and analyze Laboratory Controls and other metrics for Operational Reviews, QLT’s and QMR’s. May provide support to Laboratory Control PON
Provides support to implementation of QMS as relevant to Analytical QA functions
Provides support to QA management with process improvement activities. Identifies and facilitates continuous improvement efforts and leads continuous improvement projects as assigned
Provides tactics to address compliance gaps or determines enhancements to cross-functional quality systems
Conducts review of procedures, SOP’s and work instructions
Supports and conducts data review and COA generation as needed
Provides back-up support for other projects when needed. Assists with internal audits and external regulatory agency inspections when needed
Responsible for the following activities related to people management responsibilities
Talent Development and Coaching
Performance Management (goals, monitoring, reviews)
Monitoring /Supporting Employee Engagement
Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs
Accountable to provide oversight of day-to-day operations
Assists with workforce planning/resource modeling
Qualification
Required
Master's degree and 5-8 years of work experience in a scientific or allied health field, or Bachelor's degree in a scientific or allied health field and 10+ years of relevant work experience, or relevant comparable background
Preferred
Broad GxP Knowledge across Product lifecycle. In-depth knowledge of global GMP requirements
Ability to think critically and strategically with clear goals in mind
Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
Demonstrated ability to manage teams and to develop personnel. Demonstrated ability to mentor and guide staff and transfer technical knowledge and teaching quality management skills
Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; ability to work outside of precedent and takes a new perspective on existing solutions
Ability to communicate cross-functionally to a wide variety of audiences, question stakeholders to understand their needs
Successful track record influencing cross functional teams and gain alignment on proposed actions
Strong experience in leading Quality Events investigations, Root Cause Analysis (RCA), and CAPA implementation
Demonstrated ability to independently lead cross-functional teams and to provide QA advice for large, multifaceted projects
Strong laboratory/QC experience and understanding of various analytical techniques
Ability to effectively organize and plan activities
Experience in Presentations and Risk Management
Operational QA experience in analytical or manufacturing setting is desired
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
Represents job field similar to this job
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