Associate Director, Operational Quality Product Launch

Vertex Inc.•Boston, MA

11d•Hybrid

About The Position

The Associate Director of GMP Operational Quality Assurance is an advanced technical resource and is recognized as an expert internally 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 all regulatory requirements. The Associate Director of Quality Assurance is responsible for oversight of multiple new product launches, ensuring effective alignment with business timelines and compliance with relevant global regulatory requirements. This role is expected to work closely with business partners and stakeholders to ensure successful market launch and expansion of existing brands in markets globally. The role is responsible for coordinating and/or or executing activities on multiple complex projects and takes a role in the design and execution of new projects. This position reports directly to the Director of GMP Operational Quality.

Requirements

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
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
Collaboration / Teamwork / Conflict Management
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
Critical Thinking / Problem Solving: 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

Nice To Haves

Experience providing Quality support and oversight of GMP manufacturing operation at Contract Manufacturing Organizations and Contract Test Laboratories including batch release 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

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
External QP Relationship and Release
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.
Establishment of Quality Processes/Process Ownership – Product Launch Quality Management System of Global Commercial Finished Goods
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
Quality Agreement Oversight Program:
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