GMP Operational Quality Manager (QA on the Floor)

Vertex Inc.•Boston, MA

3d•$118,400 - $177,600•Onsite

About The Position

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities “on the floor” in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.

Requirements

Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.
Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
Formal project management experience
Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.
Able to integrates activities with other groups, departments and project teams as needed.
Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
Excellent team player and collaborator
Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Responsibilities

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Perform change control assessments and closure approvals
Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
Collect data and report on metrics
Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
Lead continuous improvement projects
Author SOP's to support commercial quality functions.
Assist with regulatory agency inspections
Identify and facilitate continuous improvement efforts
Train employees and provide insights and education on processes and procedures.
Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
Gown into cleanrooms and controlled environments