GMP Operational Quality Manager (QA on the Floor)

Vertex Inc. • Boston, MA

2d • Onsite

About The Position

General Summary: 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)
• Bachelor's degree in scientific or allied health field (or equivalent degree)
• Typically requires 4+ years of experience, or the equivalent combination of education and experience

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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to 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) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees