GMP Operational Quality Manager; QA Floor

Position: GMP Operational Quality Manager (QA on the Floor)
Job Description

General

Summary:

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities "on the floor" in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.

Key

Duties and Responsibilities:

* Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions

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

* Perform change control assessments and closure approvals

* Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed

* Collect data and report on metrics

* Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.

* Lead continuous improvement projects

* Author SOP's to support commercial quality functions.

* Assist with regulatory agency inspections

* Identify and facilitate continuous improvement efforts

* Train employees and provide insights and education on processes and procedures.

* Perform activities associated with product disposition (e.g., batch document review, source data review etc.)

* Gown into clean rooms and controlled environments

Knowledge and

Skills:

* Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting

* Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.

* Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint

* Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes

* Formal project management experience

* Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.

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

* Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions

* Excellent team player and collaborator

* Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

* Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Education and Experience:

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

* Typically requires 4+ years of experience, or the equivalent combination of education and experience

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Pay Range:

$118,400 - $177,600

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:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will 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.

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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…