Quality Assurance Manager

2 weeks ago

Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Description

General Position Summary:

The Quality Manager is a senior technical resource in the principles and application of Quality Assurance and compliance, specifically in process validation and technical transfers. This role coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects.

The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This is a Hybrid role based out of the Boston office.

This position reports directly to the Associate Director of GMP Operational Quality.

Key Responsibilities:
  • Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to Validation and Tech Transfer manufacturing operations within Vertex or at contracted suppliers.
  • Contributes to the Validation strategy for new products and second sources to ensure compliance to regulations and risk mitigation strategies.
  • Conducts Validation and Tech Transfer GMP document reviews including Master Validation Plans, Protocols, and Reports.
  • Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls.
  • Conducts quality investigations/deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis, product and process validation impact assessments for investigations resulting from deviations and OOS.
  • Ensures product knowledge transfer to the Quality Operations team.
  • Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.
  • Supports the onboarding of Qualified vendors through the establishing of Quality Operations oversight.
  • Participates in Preapproval Inspection Readiness activities by collaborating with the Compliance team and contracted suppliers.
  • Identifies and communicates risks and assist with risk mitigation plans as necessary.
  • Contributes to the creation and review of Inspection Storyboards.
  • Assists in review of audit responses and CAPA closures.
  • Provides technical advice for regulatory agency audits.
  • Identify, facilitate, and/or lead continuous improvement efforts.
  • Maintains Quality Metrics to support process improvement activities.
Minimum Qualifications:
  • Experience providing Quality support and oversight of GMP manufacturing operations for validations and tech transfers.
  • Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.
  • In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
  • Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives.
  • Experience leading complex projects/teams 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.
  • 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.
  • Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
  • Strong experience with electronic document management systems.
  • Ability to travel domestically and internationally up to 20%.
Education and Experience:

Bachelor's degree in a scientific or allied health field with 5+ years of relevant work experience, or the equivalent combination of education and experience.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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

  • Hybrid: work remotely up to two days per week;
  • 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.

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