GMP Operational Quality Manager (QA on the Floor)
Vertex Pharmaceuticals
9 hours ago
On-site
Boston, MA
$118,400 - $177,600 USD yearly
Operations
General Summary:
- The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. Performs and leads “on the floor” activities in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. Coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.
Key Duties and 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 related to deviations, OOS, and OOT; ensure 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
- Lead continuous improvement projects
- Author SOPs 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)
- Gown into cleanrooms and controlled environments
Knowledge and Skills:
- Good understanding of the conceptual and practical application of cGMPs in a pharmaceutical setting
- Proven experience leading straightforward projects/teams within objectives and timelines
- Ability to communicate effectively with cross-functional team members and influence/guiding others
- Ability to manage own workload to achieve goals and share information to help others understand technical processes
- Formal project management experience
- Strong written and verbal communication skills for a variety of audiences
- Ability to integrate activities with other groups, departments, and project teams
- Demonstrated ability to evaluate quality matters and solve problems using technical experience and advanced judgment
- Excellent team player and collaborator
- Highly proficient in event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent)
- Typically requires 4+ years of experience, or the equivalent combination of education and experience
- The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. Performs and leads “on the floor” activities in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. Coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.
Key Duties and 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 related to deviations, OOS, and OOT; ensure 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
- Lead continuous improvement projects
- Author SOPs 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)
- Gown into cleanrooms and controlled environments
Knowledge and Skills:
- Good understanding of the conceptual and practical application of cGMPs in a pharmaceutical setting
- Proven experience leading straightforward projects/teams within objectives and timelines
- Ability to communicate effectively with cross-functional team members and influence/guiding others
- Ability to manage own workload to achieve goals and share information to help others understand technical processes
- Formal project management experience
- Strong written and verbal communication skills for a variety of audiences
- Ability to integrate activities with other groups, departments, and project teams
- Demonstrated ability to evaluate quality matters and solve problems using technical experience and advanced judgment
- Excellent team player and collaborator
- Highly proficient in event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent)
- Typically requires 4+ years of experience, or the equivalent combination of education and experience