GMP Operational Quality Senior Specialist

Vertex Pharmaceuticals•Boston, MA

3d•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 wide range of straightforward activities and contributes to new and existing project initiatives. It provides quality oversight for investigations and related corrective and preventive actions, supports change control, facilitates continuous improvement, helps draft and revise Quality Agreements, and represents Vertex Quality on cross-functional teams. Vertex describes this role as hybrid-eligible or on-site eligible. In the hybrid designation, employees may work remotely up to two days per week; in the on-site designation, employees work on-site five days per week with ad hoc flexibility. The flex status is subject to Vertex policy and may change. The position is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with applicable requirements. Vertex's Total Rewards offerings include medical, dental and vision benefits, paid time off (including a week-long company shutdown in summer and winter), educational assistance programs including student loan repayment, a commuting subsidy, matching charitable donations, and a 401(k).

Requirements

Bachelor's degree in a scientific or allied health field, or equivalent degree.
Typically 2 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 in deviation, OOS, and OOT investigations, ensuring appropriate CAPA actions are identified.
Support change control assessments, implementation, and closure.
Identify and facilitate continuous improvement efforts.
Help draft and revise Quality Agreements between CMOs or suppliers and Vertex, as needed.
Help represent Vertex Quality on cross-functional working teams, applying communication and collaboration skills.
Support continuous improvement projects.