Metrics and Reporting Manager

  • location: New Haven, CT
  • type: Contract
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job description

Metrics and Reporting Manager

job summary:
This position will be responsible for gathering Quality metrics, analyzing, trending and developing presentation content for all locations and Quality Management Reviews to evaluate performance, risks and alignment with current expectations. Metrics and Reporting Manager will also serve as a cross-functional lead and/or project manager for key initiatives resulting from the analysis of the performance metrics.

Metrics and Reporting Manager will be responsible for maintaining and improving Quality System processes and the analytical tools to be used by the Quality and applicable Operations functions, using the appropriate Lean/Six Sigma tools and communication tools to improve performance and ensure best practices are implemented as needed.

Principal Responsibilities

  1. Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
  2. Manage the implementation of key Continuous Improvement projects as needed.
  3. Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
  4. Administer Quality analytics processes and develop statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
  5. Compile data and develop analysis to support Quality Management Reviews
  6. Lead contact for assistance in conducting establishing trending analysis of existing and new Quality System processes
  7. Provide input and support managing Quality system analysis documentation schedules and sample plans.
  8. Support the management of the Quality Systems Team as needed
  9. Active partner across the company's GXP groups, providing support and consultation
  10. Perform other related duties and special projects as required or requested.
Qualifications

  • 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement
  • Hands-on experience as a project manager
  • Lean/Six Sigma Green Belt certification
  • Thorough knowledge of cGMPs, GXPs and Quality Systems required
  • Working experience in risk management and or operational excellence
  • Operations experience in a GMP environment a plus Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Proficiency with statistical analysis methodologies and programs
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail
  • Multifunctional experience to include operations management, quality system development and quality system analysis
Education

  • Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
  • Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).
Competencies

  • Peer Relationships
  • Technical learning
  • Action oriented
  • Accountability
  • Command skills
  • Interpersonal savvy
  • Customer focus
 
location: New Haven, Connecticut
job type: Contract
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
This position will be responsible for gathering Quality metrics, analyzing, trending and developing presentation content for all locations and Quality Management Reviews to evaluate performance, risks and alignment with current expectations. Metrics and Reporting Manager will also serve as a cross-functional lead and/or project manager for key initiatives resulting from the analysis of the performance metrics.

Metrics and Reporting Manager will be responsible for maintaining and improving Quality System processes and the analytical tools to be used by the Quality and applicable Operations functions, using the appropriate Lean/Six Sigma tools and communication tools to improve performance and ensure best practices are implemented as needed.

Principal Responsibilities

  1. Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
  2. Manage the implementation of key Continuous Improvement projects as needed.
  3. Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
  4. Administer Quality analytics processes and develop statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
  5. Compile data and develop analysis to support Quality Management Reviews
  6. Lead contact for assistance in conducting establishing trending analysis of existing and new Quality System processes
  7. Provide input and support managing Quality system analysis documentation schedules and sample plans.
  8. Support the management of the Quality Systems Team as needed
  9. Active partner across the company's GXP groups, providing support and consultation
  10. Perform other related duties and special projects as required or requested.
Qualifications

  • 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement
  • Hands-on experience as a project manager
  • Lean/Six Sigma Green Belt certification
  • Thorough knowledge of cGMPs, GXPs and Quality Systems required
  • Working experience in risk management and or operational excellence
  • Operations experience in a GMP environment a plus Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Proficiency with statistical analysis methodologies and programs
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail
  • Multifunctional experience to include operations management, quality system development and quality system analysis
Education

  • Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
  • Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).
Competencies

  • Peer Relationships
  • Technical learning
  • Action oriented
  • Accountability
  • Command skills
  • Interpersonal savvy
  • Customer focus
 
qualifications:
This position will be responsible for gathering Quality metrics, analyzing, trending and developing presentation content for all locations and Quality Management Reviews to evaluate performance, risks and alignment with current expectations. Metrics and Reporting Manager will also serve as a cross-functional lead and/or project manager for key initiatives resulting from the analysis of the performance metrics.

Metrics and Reporting Manager will be responsible for maintaining and improving Quality System processes and the analytical tools to be used by the Quality and applicable Operations functions, using the appropriate Lean/Six Sigma tools and communication tools to improve performance and ensure best practices are implemented as needed.

Principal Responsibilities

  1. Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
  2. Manage the implementation of key Continuous Improvement projects as needed.
  3. Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
  4. Administer Quality analytics processes and develop statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
  5. Compile data and develop analysis to support Quality Management Reviews
  6. Lead contact for assistance in conducting establishing trending analysis of existing and new Quality System processes
  7. Provide input and support managing Quality system analysis documentation schedules and sample plans.
  8. Support the management of the Quality Systems Team as needed
  9. Active partner across the company's GXP groups, providing support and consultation
  10. Perform other related duties and special projects as required or requested.
Qualifications

  • 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement
  • Hands-on experience as a project manager
  • Lean/Six Sigma Green Belt certification
  • Thorough knowledge of cGMPs, GXPs and Quality Systems required
  • Working experience in risk management and or operational excellence
  • Operations experience in a GMP environment a plus Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Proficiency with statistical analysis methodologies and programs
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail
  • Multifunctional experience to include operations management, quality system development and quality system analysis
Education

  • Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
  • Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).
Competencies

  • Peer Relationships
  • Technical learning
  • Action oriented
  • Accountability
  • Command skills
  • Interpersonal savvy
  • Customer focus
 
skills: This position will be responsible for gathering Quality metrics, analyzing, trending and developing presentation content for all locations and Quality Management Reviews to evaluate performance, risks and alignment with current expectations. Metrics and Reporting Manager will also serve as a cross-functional lead and/or project manager for key initiatives resulting from the analysis of the performance metrics.

Metrics and Reporting Manager will be responsible for maintaining and improving Quality System processes and the analytical tools to be used by the Quality and applicable Operations functions, using the appropriate Lean/Six Sigma tools and communication tools to improve performance and ensure best practices are implemented as needed.

Principal Responsibilities

  1. Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
  2. Manage the implementation of key Continuous Improvement projects as needed.
  3. Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.
  4. Administer Quality analytics processes and develop statistical analysis and reporting mechanisms for GXP systems and processes. To include systems to enhance monitoring, trending and signaling as relates to applicable data sources.
  5. Compile data and develop analysis to support Quality Management Reviews
  6. Lead contact for assistance in conducting establishing trending analysis of existing and new Quality System processes
  7. Provide input and support managing Quality system analysis documentation schedules and sample plans.
  8. Support the management of the Quality Systems Team as needed
  9. Active partner across the company's GXP groups, providing support and consultation
  10. Perform other related duties and special projects as required or requested.
Qualifications

  • 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement
  • Hands-on experience as a project manager
  • Lean/Six Sigma Green Belt certification
  • Thorough knowledge of cGMPs, GXPs and Quality Systems required
  • Working experience in risk management and or operational excellence
  • Operations experience in a GMP environment a plus Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Proficiency with statistical analysis methodologies and programs
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail
  • Multifunctional experience to include operations management, quality system development and quality system analysis
Education

  • Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
  • Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).
Competencies

  • Peer Relationships
  • Technical learning
  • Action oriented
  • Accountability
  • Command skills
  • Interpersonal savvy
  • Customer focus

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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