GMP Operational Quality Senior Specialist

MFS Investments; Boston (MA); Ibrido; USD 94.000 - 141.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid-Eligible

Annual bonus

Equity awards

Total Rewards benefits

Descrizione del lavoro

Vertex is seeking a GMP Operational Quality Senior Specialist in Boston to support quality assurance and regulatory compliance across investigations, CAPA, and change control. The role emphasizes root-cause analysis, product impact assessments, and collaboration with cross-functional teams.

The ideal candidate has a Bachelor's degree in a scientific field, 2+ years of relevant experience, and strong communication skills in a fast-paced, cGMP pharmaceutical setting.

Competenze

• Experience supporting multiple projects within objectives and timelines.
• Experience supporting cross-functional team members and collaborating effectively.
• Strong written and verbal communication skills.
• Able to integrate activities with other groups and project teams.
• Ability to evaluate quality matters and solve straightforward problems using precedent.

Mansioni

• Supports quality oversight for root-cause analysis and product impact assessment for investigations (deviations, OOS, OOT).
• Supports change control assessments, implementation and closure.
• Identifies and facilitates continuous improvement efforts.
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex.
• Represents Quality on cross-functional teams with strong communication and collaboration.
• Supports continuous improvement projects.

Conoscenze

Root Cause Analysis

CAPA

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Excellent communication

Formazione

Bachelor's degree in scientific field

Descrizione del lavoro

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

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.

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 [e-mail]