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Senior Manager, Quality Analytical Microbiology Cell and Gene (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Thursday, May 9, 2024

Job Description

General Summary:

The Senior Manager, Quality Analytical Microbiology is an advanced technical resource in the principles and application of microbiology quality assurance and compliance. The Senior Manager, Quality Analytical Microbiology coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects.

Key Duties and Responsibilities:

Collaborate with internally and external business partners to resolve complex quality issues related to microbiology to ensure compliant solutions

Participates in cross-functional teams as an experienced Quality technical resource

Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

Ensures appropriate CAPA actions are properly identified and addressed, approves investigations/CAPAs.

Assists Change Control owners with ensuring compliance to change procedure requirements

Assesses and approves change controls

Identify, facilitate, and/or lead continuous improvement efforts

Maintains Quality Metrics to support process improvement activities

Provides tactics to address compliance gaps or recommends enhancements to cross- functional quality systems

Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports

Identify and communicate risks and assist with risk mitigation plans as necessary

Supports internal audit or external audit programs

Assists in preparation of audit responses, BLA, MAA, IND/IMPD submissions

Drafts and enforces Quality Agreements between CDMOs/Suppliers and Vertex, as needed

Provides technical advice in relation to microbiology for partner and regulatory agency audits

Provides information to assist in budgeting and scheduling

Knowledge and Skills:

  • In-depth knowledge of Microbiology assays including assay validation / verification, and contamination control strategy

  • Strong experience in cell and gene therapy/Biologics

    Strong CMC/Regulatory experience

    In-depth knowledge of electronic document management systems (e.g., QDoccs, Veeva).

    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 independently lead cross-functional teams and represent the Quality unit, and to mentor and guide less experienced colleagues, skilled at transferring technical knowledge and teaching quality management skills

    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

    Demonstrated ability to work independently to provide QA advice for large, multifaceted projects

Education and Experience:

  • Bachelor's degree in a microbiology scientific or allied health field (or equivalent degree)
  • Typically requires 6 years of experience in microbiology, or the equivalent combination of education and experience

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND2

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.