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Senior Manager, Vendor Quality Management

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Friday, December 8, 2023

Job Description

General Summary:

The Senior Manager, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GMP/GDP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues.

Key Duties and Responsibilities:

  • Responsible for Vendor Management of early phase development to commercial Quality function to ensure appropriate and timely vendor qualification and maintenance
  • Maintains and manages risk-based model for management and quality oversight of GMP and GDP vendors
  • Manage improvements and contribute to the advancement of the GMP and GDP Vendor Management program by identifying opportunities and implementing risk-appropriate enhancements to the Vendor Oversight infrastructure
  • Serve as Process Owner for GMP/GDP Quality Agreements, while driving the following responsibilities:
    • Liaise with Vertex Sourcing/Contract Management to understand and provide visibility to Vertex stakeholders regarding existing, developing, and current agreements with external vendors (e.g., Master Service/Supply Agreement, Quality Agreements, etc.)
    • Support Vertex stakeholders in ensuring adequacy of and compliance to Quality Agreements
    • Enable continuous improvement of the GMP/GDP Quality Agreement process
    • Maintain Quality Agreement Performance Dashboard and support development of performance metrics to be presented at Vertex Quality Leadership Team and Operational Review forums
  • Oversee quality and compliance monitoring across GMP/GDP vendors using vendor oversight strategies, that include but are not limited to:
    • Serve as GMP/GDP interface to vendor QA partners in support of quality management, inspection readiness and continuous improvement
    • Partner with business stakeholders for ensuring adequate governance and quality oversight across vendors
    • Develop/mature Vendor Performance Dashboards /Quality Scorecard and monitor metrics and dashboards for emerging trends across vendors
    • Guide Vertex QA teams and stakeholders to assess risk management strategies, vendor selection /remediation, and quality metrics monitoring
  • Serve as SME and participate in inspection preparation and management activities for selected vendors as appropriate.
  • Support Functional Area QA and QA Audit Team to resolve observations and quality issues arising across vendors, including but not limited to:
    • Risk/impact assessment, specifically with respect to impact across vendors
    • CAPA development, execution, effectiveness assessment
  • Maintain and evolve models and mechanisms for ensuring awareness and application of QMS requirements (e.g., qualification, quality agreements, vendor change notification process) across GMP/GDP vendors
  • Partner with QA Audit and Inspection Management team and provide input to audits of GMP/GDP vendors
  • Provides Quality consultation/direction to internal Technical Operations, Supply Chain, Process Development, and Analytical Development regarding vendor management inquiries
  • Lead and/or participate in process improvement projects to evolve quality systems/processes

Knowledge and Skills:

  • Demonstrated ability to work well in a matrixed, collaborative environment.
  • Demonstrated working knowledge and experience applying US and international/global regulatory requirements, associated guidance and standards applicable to drug, biologic, combination product, and/or device research, development, manufacturing, and distribution
  • Knowledge of regulatory requirements specific to vendor selection and oversight in one or more GxP areas
  • Strong working knowledge of risk management and issue management, with a demonstrated ability to apply to third party suppliers carrying out GMP and GDP governed activities
  • Strong oral and written communication and interpersonal skills to communicate difficult concepts and persuade others
  • Strategic "big picture" thinking while maintaining ability to collaborate effectively and execute efficiently at a tactical level
  • Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making
  • Skilled in influencing and escalating within a matrixed organization to drive decisions
  • Demonstrated experience with key performance indicators and quality metrics for vendors
  • Experience advising, coaching, or mentoring junior staff

Education and Experience:

  • M.S. (or equivalent degree) and 0-3 years of relevant work experience, or B.S. in a scientific or allied health field and 8+ years of relevant work experience, or relevant comparable background
  • Supplier relationship building and supplier expectations management
  • Experience with Vendor/Audit management in the GxP space
  • Experience participating on cross-functional teams
  • Experience using computerized systems including Electronic Document Management (eDMS), Electronic Quality Management System (eQMS) and Electronic Learning Management (eLMS)
  • Proficiency in using MS Office applications required (including MS Word, MS Excel, PowerPoint)

Pay Range $124,800.00 – $177,200.00 USD annually

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.

#LI-AR1 #LI-Remote

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