GMP Operational Quality Senior Specialist

Job Description

General Summary:

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives.

Key Duties and Responsibilities:

Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.

Supports change control assessments, implementation and closure

Identifies and facilitates continuous improvement efforts

Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed

Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.

Support continuous improvement projects

Knowledge and Skills:

Experience supporting multiple projects/teams within stated objectives and timelines

Experience supporting cross-functional team members and collaborate effectively

Good communication skills (written and verbal) and the ability to exchange potentially complex information

Able to integrates activities with other groups, departments and project teams as needed

Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent

Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives

Expanded conceptual knowledge of cGMP's in a pharmaceutical setting

Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience:

Bachelor's degree in scientific or allied health field (or equivalent degree)

Typically requires 2 years of experience, or the equivalent combination of education and experience

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$94,200 - $141,200

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]