Associate Director, Vendor Quality Management, Cell

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Vertex Full time
Job Description:

Job Description

TheVendor Quality Management Associate Directorprovides technical and strategic leadership for vendor quality, vendor quality processes, and associated governance for the cell and gene therapy business unit.This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk based compliance

Key Duties and Responsibilities:

  • Management of vendors and vendor process including onboard, risk based and phase appropriate qualification oversight, and ongoing monitoring.
  • Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
  • Provides tactics to address compliance gaps or determines enhancements to cross-functional vendor quality management process
  • Monitors health of vendor quality management system as well as vendor performance through audits, inspections, SCARs, and other inputs. Ensures escalation and increased governance of low performing vendors and tracks the risks and mitigation plans.
  • Work with global quality and functional areas to ensure vendor qualification program is scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations
  • Proactively identify ways to improve efficiency and effectiveness of processes which may include quality system process improvements, improving existing methodologies, data generation, report development and presentation

Requirements:

  • Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field
  • Typically requires 8 years of experience or the equivalent combination of education and experience
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Strong technical knowledge including but not limited to: vendor management, risk management, auditing techniques, and quality governance
  • Ability to understand and translate customer needs
  • Proven Ability to lead improvement projects and project teams
  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
  • Experience across multiple GxP areas
  • Proven ability to identify and analyze performance indicators.

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.

Job Description

TheVendor Quality Management Associate Directorprovides technical and strategic leadership for vendor quality, vendor quality processes, and associated governance for the cell and gene therapy business unit.This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk based compliance

Key Duties and Responsibilities:

  • Management of vendors and vendor process including onboard, risk based and phase appropriate qualification oversight, and ongoing monitoring.
  • Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
  • Provides tactics to address compliance gaps or determines enhancements to cross-functional vendor quality management process
  • Monitors health of vendor quality management system as well as vendor performance through audits, inspections, SCARs, and other inputs. Ensures escalation and increased governance of low performing vendors and tracks the risks and mitigation plans.
  • Work with global quality and functional areas to ensure vendor qualification program is scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations
  • Proactively identify ways to improve efficiency and effectiveness of processes which may include quality system process improvements, improving existing methodologies, data generation, report development and presentation

Requirements:

  • Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field
  • Typically requires 8 years of experience or the equivalent combination of education and experience
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Strong technical knowledge including but not limited to: vendor management, risk management, auditing techniques, and quality governance
  • Ability to understand and translate customer needs
  • Proven Ability to lead improvement projects and project teams
  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
  • Experience across multiple GxP areas
  • Proven ability to identify and analyze performance indicators.

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.

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