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