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

Pay Range:
$94,200 - $141,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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