Senior Manager, Analytical Quality Assurance
Full Time
Boston, MA 02110
Posted
Job description
Job Description
General Summary:
The Senior Manager, Analytical Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control at Vertex Cell and Gene Therapy as well as quality assurance support of outsourced laboratories, ensuring cGMP/cGLP compliance, compliance with current regulatory guidance, and industry best practices. Activities in scope of this role include release analytical testing, stability testing, and QA support for out of specification investigations. The Senior Manager, Analytical Quality will be accountable and/or assist in the end-to-end quality control oversight of cell and gene therapy program(s) throughout clinical development, commercialization, filing, approval, launch , and post approval lifecycle management activities.
Key Duties and Responsibilities:
- Serve as a Quality Assurance Point of Contact for quality related to QC issues
- Collaborate and partner with Vertex QC team to conduct/resolve deviations, identify CAPA sand complete change controls in compliance with regulatory requirements
- Maintain oversight of internal QC activities and provide quality guidance to external contract laboratories to assure compliance
- Perform/assist with the review of out of specification, analytical testing data and Certificates of Analysis in support of product release
- Ensure Vertex stability program is conducted in compliance with established protocols and applicable regulations
- Support life cycle management activities associated with analytical development such as stability and shelf life
- Participate in regulatory submissions, updates, and responses
- Support development of Vertex quality systems and processes, draft/revise SOPs, policies and work instructions
- Lead / Participates in cross-functional projects.
- Identify, facilitate, and/or lead continuous improvement efforts
Knowledge and Skills:
- Broad experience and knowledge of QA and QC activities in cell therapies
- Prior experience working with/managing internal QC lab and external Test labs.
- Strong Quality Control or Quality Assurance over QC activities
- In-depth knowledge of electronic document management systems (e.g., QDoccs, Veeva)
- Identify, facilitate, and/or lead continuous improvement efforts
- Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
- In-depth experience leading complex projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
- Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action
Education and Experience:
- Bachelor's degree in a scientific or allied health field (or equivalent degree)
- 6 years of experience in a regulated pharmaceutical environment.
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:
1. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
#LI-AR1 #LI-Hybrid
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.
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