Quality Auditing Services Manager -Remote

takeda

Boston Massachusetts

United States

Customer Service / Call Center
(No Timezone Provided)

OBJECTIVES/PURPOSE

:

  • Execute direction and governance to sites, operating units and functions for self inspection and internal auditing processes
  • Implement risk based approach to the auditing program underpinned by PTRB
  • Complete tasks associated Business Process ownership of audit management systems and processes, Business Development & Due Diligence, Auditing Risk Assessment, Project Management, Quality audits of GMS and LOCs, Audit Planning/ Monitoring/ Reporting, and/ or Inspection readiness.
  • May be a Key Contact for Operating units for auditing activities and services
  • ACCOUNTABILITIES :

  • Implement and execute audit activities within Takeda which focuses on a risk based approach to self inspection and auditing which identifies and resolves risks
  • Execute unified and shared audit services platform throughout Takeda to enable consistent and effective audit operations and Due Diligence audit support activities worldwide
  • Carry-out strategic direction and provide oversight pertaining to auditing which achieves sustained success for regulatory inspections and supply chain product quality
  • Enact global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditing
  • Execute duties associated with one or more of the following:
  • Business Process ownership of audit management systems and processes
  • Business Development & Due Diligence: provide subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Auditing Risk Assessment: further develop and deploy risk assessment program
  • Project Management: Oversee Project Management activities within the group including visibility, tracking, implementation and governance through change and project management
  • Quality audits of GMS, LOCs, and/or suppliers
  • Audit Planning/ Monitoring/ Reporting: coordinate global audit planning / scheduling to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan by working with Site QA auditors, Supplier Quality management and Internal auditors.
  • Inspection readiness: develop and deploy an inspection readiness program for activities at a site, regional and global level
  • May require up to 50% travel
  • Other duties as assigned
  • DIMENSIONS AND ASPECTS

    Technical/Functional (Line) Expertise:

  • Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines Manufacturing
  • Knowledge and understanding of therapeutic areas as well as scientific advances and modalities for treating diseases.
  • Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
  • Leadership:

  • Ability to lead the quality audit teams and support projects across Quality Auditing and Supplier Quality
  • Tactical role to help develop, deploy and govern the quality auditing processes and tools to sites / regions and global function
  • Decision-making and Autonomy:

  • A member of the Quality Auditing and Services team
  • Responsible for risk identification for internal sites and operating units and resolution of incidents
  • Interaction:

  • Align and partner with Quality Auditing & Supplier Quality regarding execution of responsibilities
  • Partner with Operating units to support business priorities from an audit perspective
  • Communicate and train sites, operating units and global functions regarding audit management and self-inspections
  • Innovation:

  • A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry
  • Complexity :

    The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas

    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Scientific degree (BSc, MSc)
  • 8+ years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
  • Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
  • Effective finance and controlling knowledge and competencies to manage mid-range organization
  • Fluent in written and spoken English and French or English and German- is highly desired!
  • Core Competencies / Skills

  • Critical Thinking
  • Current on local and global regulations
  • Digital and analytical skills
  • Investigation and problem solving
  • Strong communication skills engaging stakeholders: site, business, network, company, regulators
  • Risk identification, evaluation and management
  • Continuous improvement
  • Leadership Behaviors

  • Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
  • Creating the environment that inspires and enables people
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

  • This job posting excludes CO applicants.

    Quality Auditing Services Manager -Remote

    takeda

    Boston Massachusetts

    United States

    Customer Service / Call Center

    (No Timezone Provided)

    OBJECTIVES/PURPOSE

    :

  • Execute direction and governance to sites, operating units and functions for self inspection and internal auditing processes
  • Implement risk based approach to the auditing program underpinned by PTRB
  • Complete tasks associated Business Process ownership of audit management systems and processes, Business Development & Due Diligence, Auditing Risk Assessment, Project Management, Quality audits of GMS and LOCs, Audit Planning/ Monitoring/ Reporting, and/ or Inspection readiness.
  • May be a Key Contact for Operating units for auditing activities and services
  • ACCOUNTABILITIES :

  • Implement and execute audit activities within Takeda which focuses on a risk based approach to self inspection and auditing which identifies and resolves risks
  • Execute unified and shared audit services platform throughout Takeda to enable consistent and effective audit operations and Due Diligence audit support activities worldwide
  • Carry-out strategic direction and provide oversight pertaining to auditing which achieves sustained success for regulatory inspections and supply chain product quality
  • Enact global audit policies, guidance, standards, procedures governing self inspection, risk identification and auditing
  • Execute duties associated with one or more of the following:
  • Business Process ownership of audit management systems and processes
  • Business Development & Due Diligence: provide subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Auditing Risk Assessment: further develop and deploy risk assessment program
  • Project Management: Oversee Project Management activities within the group including visibility, tracking, implementation and governance through change and project management
  • Quality audits of GMS, LOCs, and/or suppliers
  • Audit Planning/ Monitoring/ Reporting: coordinate global audit planning / scheduling to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan by working with Site QA auditors, Supplier Quality management and Internal auditors.
  • Inspection readiness: develop and deploy an inspection readiness program for activities at a site, regional and global level
  • May require up to 50% travel
  • Other duties as assigned
  • DIMENSIONS AND ASPECTS

    Technical/Functional (Line) Expertise:

  • Knowledge and experience of Bio-Pharmaceutical, R&D and/ or Vaccines Manufacturing
  • Knowledge and understanding of therapeutic areas as well as scientific advances and modalities for treating diseases.
  • Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
  • Leadership:

  • Ability to lead the quality audit teams and support projects across Quality Auditing and Supplier Quality
  • Tactical role to help develop, deploy and govern the quality auditing processes and tools to sites / regions and global function
  • Decision-making and Autonomy:

  • A member of the Quality Auditing and Services team
  • Responsible for risk identification for internal sites and operating units and resolution of incidents
  • Interaction:

  • Align and partner with Quality Auditing & Supplier Quality regarding execution of responsibilities
  • Partner with Operating units to support business priorities from an audit perspective
  • Communicate and train sites, operating units and global functions regarding audit management and self-inspections
  • Innovation:

  • A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s regulatory profile to become the model for the industry
  • Complexity :

    The complexity in the role lies in the diversity of manufacturing techniques and facilities as the role covers all geographies and therapeutic areas

    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Scientific degree (BSc, MSc)
  • 8+ years of increasing management responsibility combined with knowledge of pharmaceutical manufacturing
  • Experience across all of the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment
  • Effective finance and controlling knowledge and competencies to manage mid-range organization
  • Fluent in written and spoken English and French or English and German- is highly desired!
  • Core Competencies / Skills

  • Critical Thinking
  • Current on local and global regulations
  • Digital and analytical skills
  • Investigation and problem solving
  • Strong communication skills engaging stakeholders: site, business, network, company, regulators
  • Risk identification, evaluation and management
  • Continuous improvement
  • Leadership Behaviors

  • Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
  • Creating the environment that inspires and enables people
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

  • This job posting excludes CO applicants.