Job Description

The Senior Manager will lead the day-to-day QA oversight including execution of batch disposition at the Vertex CPI and Drug Product Facility in support of manufacturing operations. The Quality Assurance Senior Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance at the Cell & Genetic manufacturing site.

Other key areas include QA oversight of analytical laboratory operations, environmental labs, and materials management. This role will drive, review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation across all phases of development and commercial.

This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. This is a second shift role from Sunday to Wednesday 12:30 to 11pm.

Key Duties & Responsibilities

• Responsible for leading quality oversight of shift manufacturing operations including analytical laboratory, materials management and manufacturing operations.

• Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.

• Provide QA support of change controls, process and OOS investigations, and associated CAPAs.

• Responsible for approval of Manufacturing & QA documents e.g. MBR, APSs, COAs and product labelling.

• Support technical transfer, review and approval of manufacturing documents and process performance qualification activities.

• Responsible for proactive identification of compliance risks and gaps for GMP processes including execution and implementation of mitigating controls

• Support audit and inspection readiness activities.

• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.

• Maintain, track and report performance and batch record metrics.

• Execute improvements to QA operations processes.

• Participate/ lead Cell & Genetic Program and Quality projects and drive continuous improvement activities.

Required Education Level

• Bachelor's degree in a biotech/ Life sciences field.

• Preferred Master's degree or relevant comparable background.

Required Experience

• 6+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

• Demonstrated experience providing/leading QA support to GMP manufacturing operation on the manufacturing floor and as a QA reviewer working with Batch Records or in QC Analytical role.

• Experience successfully leading event investigations, Root Cause Analysis and CAPA

• Experience with network-based applications such as Oracle, Veeva

• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)

• In depth knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

• Critical Thinking and Problem Solving with ability to evaluate quality matters and make decisions utilizing risk based approach

• Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.

• Strong leadership skills with the ability to thrive in a high throughput environment

• Results driven and attention to detail to execute in a QA operational role.

• Ability to effectively communicate and influence others

• Excellent collaboration skills, and teamwork to partner within Quality and with stakeholders .

Other Requirements

• Up to 5% Travel may be required

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.

Pay Range:

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:

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 ApplicationAssistance@vrtx.com