Quality Assurance Senior Specialist, Engineering​/Validation

The Senior Quality Specialist will provide QA support for commissioning, Qualification and Validation (CQV), and project-related QA activities at Vertex Manufacturing Center (VMC), Boston, MA.

As a key member of our Quality Assurance team, this person will be responsible for ensuring the quality and compliance of our facilities, equipment, and utilities through meticulous review, guidance, and collaboration with stakeholders. This person will leverage their project management expertise and deep understanding of quality systems to facilitate successful CQV projects and maintain the integrity of our manufacturing processes.

The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs.

The position will support multiple production functions (from Quality operations to Quality Engineering) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with a cross-functional team, as needed. Advising Production on proper documentation as needed and performing other duties as assigned.

This role will require local presence at the VMC, Boston site.

Key Leadership

Skills:

• Cross-functional collaborator
• Results Driver

Key Knowledge/ Skills and

Competencies:

• Strong leadership skills with the ability to thrive in a high throughput environment
• Critical Thinking / Problem-Solving
  • Ability to evaluate quality matters and make decisions
• Strong oral and written communication skills required
• Good Interpersonal skills required
• Attention to detail
• Knowledge in the following areas:
  • Knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • Ability to work under limited supervision

Oversight of Internal Operations – Quality Engineering:

• Provide QA oversight and support for Commissioning, Qualification, and Validation projects for facilities, equipment, and utilities, ensuring alignment with project timelines and quality standards.
• Review and approve comprehensive qualification and validation strategies and plans developed by stakeholders.
• Critically review and approve qualification protocols (IQ, OQ, PQ) and validation protocols (e.g., process validation) for accuracy, completeness, and compliance.
• Analyze qualification and validation data presented by stakeholders, review reports for accuracy and completeness, and provide QA input on findings.
• Independently author and manage quality system records, including deviations, change controls, and Corrective and Preventative Actions (CAPAs) related to qualification and validation activities, often initiated by or in collaboration with stakeholders.
• Provide expert QA guidance and support during the execution of qualification and validation protocols by cross-functional teams.
• Collaborate effectively with cross-functional teams, including Engineering, Manufacturing, and Quality Control, to ensure a productive and compliant approach to CQV.
• Participate in risk assessments related to facilities, equipment, and utilities, providing a QA perspective and critical evaluation.
• Contribute to the development and improvement of quality assurance procedures and policies related to validation, facility, and engineering standards through insightful review and recommendations.
• Critically review and assess CQV documentation and activities, providing constructive feedback and guidance to stakeholders.
• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via…