GMP Operational Quality Senior Specialist

Vertex Inc. • Boston, MA

6d • $94,200 - $141,200 • Hybrid

About The Position

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The role supports or executes a range of straightforward activities and contributes to new and existing project initiatives.

The position provides quality oversight for investigations involving deviations, out-of-specification (OOS), and out-of-trend (OOT) results, including root-cause analysis, product-impact assessment, and identification of appropriate CAPA actions. It also supports change-control assessments, implementation, and closure, as well as continuous-improvement efforts and drafting or revising Quality Agreements between CMOs or suppliers and Vertex.

The specialist represents Vertex Quality on cross-functional working teams and collaborates with colleagues across groups and departments. Vertex encourages continuous learning about AI, technology, automation, and industry trends, and the role calls for curiosity, sound judgment, and thoughtful adoption of capabilities that improve decision-making, innovation, efficiency, and patient outcomes.

The position is hybrid-eligible or on-site eligible. Employees designated hybrid may work remotely up to two days per week; employees designated on-site work five days per week on-site, with ad hoc flexibility. Flex status is subject to Vertex policy and may change. The stated base salary range is $94,200–$141,200. The role is eligible for an annual bonus and annual equity awards; some roles may also qualify for overtime pay. Actual base salary depends on relevant factors including skills, competencies, and experience.

Requirements

• Bachelor's degree in a scientific or allied health field, or equivalent degree.
• Typically two years of experience, or an equivalent combination of education and experience.
• Experience supporting multiple projects or teams within stated objectives and timelines.
• Experience supporting cross-functional team members and collaborating effectively.
• Good written and verbal communication skills, including the ability to exchange potentially complex information.
• Ability to integrate activities with other groups, departments, and project teams as needed.
• Demonstrated ability to evaluate quality matters and solve straightforward problems using technical experience and judgment based on precedent.
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
• Proficiency in leading event investigations, root-cause analysis (RCA), and CAPA.

Responsibilities

• Support quality oversight for root-cause analysis and product-impact assessments for deviation, OOS, and OOT investigations, ensuring appropriate CAPA actions are identified.
• Support change-control assessments, implementation, and closure.
• Identify and facilitate continuous-improvement efforts and support continuous-improvement projects.
• Support drafting and revising Quality Agreements between CMOs or suppliers and Vertex, as needed.
• Represent Vertex Quality on cross-functional working teams, using communication and collaboration skills.
• Support new and existing project initiatives and coordinate activities with other groups, departments, and project teams as needed.

Benefits

• Annual bonus eligibility
• Annual equity awards
• Medical, dental, and vision benefits
• Generous paid time off, including a week-long company shutdown in summer and winter
• Educational assistance programs, including student loan repayment
• Commuting subsidy
• Matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior