GMP Operational Quality Manager

Job Description

General Summary:

The Quality Manager is a technical resource in the principles and application of quality assurance operations and compliance. 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.

This is on-site job at the Leiden Center

Key Duties and Responsibilities:

• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions.
• Lead the Working cell banks, intermediate and drug product dispositions activities.
• Perform change control assessments for the disposition and review batch manufacturing documents.
• Establish and revise the appropriate SOP's with quality assurance operations.
• Collect data and report on metrics associated with right first batch record review.
• Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
• Lead continuous improvement projects in functional department
• Author SOP's to support commercial quality functions as needed
• Assist with regulatory agency inspections as needed.
• Identify and facilitate continuous improvement efforts

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
• 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

#onsite

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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]