Associate Director, GMP Operational Quality (Hybrid)

Vertex Inc.•Boston, MA

51d•Hybrid

About The Position

The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and functional activities.

Requirements

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
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.
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

Nice To Haves

Operational QA experience in analytical or manufacturing setting is desired.

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