Quality Assurance Sr. Specialist (Contract) 905

Vertex Pharmaceuticals•Boston, MA

7d•$65 - $70

About The Position

The Senior Specialist applies functional knowledge of quality assurance principles and regulatory compliance to support timely delivery of developmental programs. The role supports or executes a range of quality activities and project initiatives, including quality systems for production and product advancement and disposition of clinical products. These products include drug substance, drug product intermediate (spray dried dispersion), bulk drug product, and finished goods. The Senior Specialist collaborates with Pharmaceutical Sciences, CMC Regulatory, GDP Finish Goods, Supply Chain, R&D Quality, and other internal Quality partners to advance programs through the product lifecycle while meeting compliance and business requirements. The role also coordinates with Vendor Management and Inspection Readiness and Audit/Inspection Management to support program-related quality activities. The ideal candidate has working knowledge of GMP regulations for early-phase through commercial drug substance and drug product manufacturing, prior Quality experience supporting drug development projects, and strong written and verbal communication skills.

Requirements

Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 3 years of relevant work experience, or an equivalent combination of education and experience.
Working knowledge of early-phase to commercial GMP drug substance and drug product manufacturing regulations.
Prior Quality experience supporting multiple projects and teams involved in drug development activities.
Practical GxP knowledge and understanding across the product lifecycle.
Knowledge of GMP regulations and their application.
Knowledge of root-cause analysis methodologies and tools.
Ability to review analytical techniques and data.
Ability to evaluate routine quality matters and make risk-based decisions.
Ability to communicate and collaborate cross-functionally with a wide variety of colleagues.
Relationship-management and conflict-management skills.

Nice To Haves

Experience supporting multiple projects and teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborating effectively.
Strong 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, and CAPA.
Operational QA experience in analytical or manufacturing settings, with small-molecule experience.
Experience with biologics, devices, or gene therapy.

Responsibilities

Support quality oversight of root-cause analysis and product-impact assessments for deviations, 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/Suppliers and Vertex, as needed.
Represent Vertex Quality on cross-functional working teams and collaborate with colleagues across relevant functions.
Review executed batch documentation from external and/or internal manufacturing and testing, including batch records, release data, in-process controls, testing, and stability data.
Use functional knowledge to inform decisions and support batch disposition for drug substance, drug product intermediate, drug product, and finished goods.
Support GMP document review, including certificates of analysis.