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General/Position Summary

The GMP Operational Quality Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The GMP Operational Quality Senior Specialist will provide QA support of manufacturing operations, and materials management for the activities supporting Cell & Genetic Therapies.

The GMP Operational Quality Senior Specialist should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. The qualified candidate will act provide quality assurance support quality systems and compliance activities working cross-functionally with R&D, Manufacturing, Supply Chain, QC and QA.

This role will review, and support activities related to incoming inspection data, batch data (including batch records, QC release testing data, deviations, CAPAs, SCARs and other quality systems documentation as need in support of product disposition.

Key Duties & Responsibilities

• Responsible for quality related incoming and WIP material management tasks.

• Supports quality related supplier approval, onboarding, and management activities.

• Responsible for quality objects for root-cause analysis and product impact assessment for investigations stemming from deviations, OOS, and OOT investigations.

• Supports change control assessments, implementation, and closure.

• Identifies and facilitates continuous improvement efforts.

• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.

• Support or execute a wide range of straight forward activities, new/existing QA/QS initiatives and continual improvement projects.

• Perform appropriate duties as assigned by management.

Required Education Level

• Bachelor's degree in a Science/ Lifesciences field.

• Preferred Master's degree or relevant comparable background.

Required Experience

4+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

• Able to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.

• Able to integrate activities with other groups, departments and project teams as needed.

• Demonstrated experience providing QA support and oversight of GMP manufacturing operation.

• Experience successfully leading event investigations, Root Cause Analysis and CAPA

• Experience with network-based applications such as Oracle, Veeva

• Understanding of regulatory environment including quality systems and compliance.

• Knowledge of ISO 13485, ISO 14971 and combination product standards is an advantage.

• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience, judgement, and a risk-based approach.

• Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.

• Ability to evaluate quality matters and make decisions utilizing risk-based approach.

• Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.

• Critical Thinking and Problem-Solving skills.

• Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND