GMP Operational Quality Assurance Manager (Contract) 28869

Atrium Works•Boston, MA

About The Position

The Quality Manager is a technical resource in the principles and application of quality assurance, quality systems, and compliance. 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, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This position reports directly to the GMP Operational Quality Senior Manager.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Chemistry, or a related discipline.
Relevant experience in Quality Assurance, Quality Operations, or a related GMP-regulated function within biotechnology, pharmaceuticals, or advanced therapies.
Demonstrated experience supporting GMP operations in a manufacturing or operational quality environment.
Strong understanding of quality systems, including deviations, CAPA, change control, investigations, and document management.
Knowledge of applicable regulatory requirements and industry expectations for GMP environments.
Experience working cross-functionally and influencing teams in a complex operational setting.
Strong problem-solving, communication, and organizational skills.
A bility to manage multiple priorities and make sound quality decisions in a fast-paced environment.
GMP / cGMP compliance
Quality systems management

Responsibilities

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions.
Provide QA support of change controls, investigations, CAPA’s, and effectiveness checks.
Draft, review, and manage approval of quality system documentation, including but not limited to, deviations, change controls, and CAPA’s.
Lead meetings, as necessary, and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
Perform Batch Record Review of Health Donar and Drug Product lots
Perform Lot Disposition of Critical Components and Drug Product lots
Perform archival activities to support lot disposition
Partner with External CDMOs
Act as subject matter expert in quality related improvement activities
Perform change control assessments and closure approvals.
Collect data and report on metrics
Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
Participate in continuous improvement projects, identify risks and communicate gaps for process/systems to ensure the team continues to meet expanding business needs.
Draft, review, and manage approval SOP's, Job Aids, and Work Instructions to support quality functions.
Support regulatory agency inspections including inspection readiness activities and supporting regulatory and internal site inpections.
Manage day-to-day activities for a Quality Assurance Associate(s)/Specialist(s), as applicable.