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QA Operations Manager

Round Lake Beach, Illinois

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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QA Operations Manager

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Job ID R0037023 Date posted 05/11/2021 Location Round Lake Beach, Illinois

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Job Description

Purpose

  • To provide leadership and oversight to quality assurance disposition function, and continuously develop people and teams.
  • To drive compliance to regulations and global policies and processes with respect to QA Disposition.
  • To ensure quality, safety and compliance of plasma derived medicinal products released to the market.

Accountabilities

  • Provide leadership and oversight to quality assurance operations function in terms of product quality and conformance to regulations and Takeda quality policies and procedures, and continuously develop people and teams.
  • Identifies and assesses quality risk in production operations daily.
  • Ability to handle multiple projects or workstreams. Demonstrates effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, problem solving and team leadership.
  • Strong leadership and collaboration skills with demonstrated success managing a multi-level team.
  • Manages site interactions with regulators concerning Quality operations.
  • May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
  • Interacts frequently with internal subordinates, functional peer and senior group managers.
  • Owns and approves Deviation/CAPA investigations related to FLEXBUMIN operations.
  • Responsible for coaching, training, and development of the QA Operations team.
  • Develops budget for department and ensures adherence to the budget.

    Establishes goals for the QA Operations department in alignment with the global and site strategy, and takes action as needed to ensure timely delivery of goals.

Working Hours

  • Working days generally week days during normal business hours. 
  • Must be available to field calls during offshift hours and weekends for decisions or quality concurrence, as needed.

Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)

  • Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
  • Strong analytical and problem-solving skills.
  • Excellent verbal and written communication skills in English.
  • Adaptive communication and presentation skills to effectively reach different levels, including senior management.
  • Skilled in Microsoft Office applications (Excel, PowerPoint, Word, Visio)

Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

  • Strong leadership skills and demonstrated success in managing a team.
  • Excellent interpersonal/communication/influencing/negotiation skills.
  • Acts as a change agent to sufficiently motivate team members to achieve team goals.

Decision-making and Autonomy

  • Must be able to deal with ambiguity, and make decisions under stressful conditions.
  • Ability to understand complex problems and anticipate consequences of actions/decisions made.

Interaction

  • Interacts with Site Head and all site functions (EHS, HR, finance, IT, production, engineering, supply chain, procurement etc.)
  • Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators.

Innovation

  • Should be familiar with Quality Risk Management principles.
  • Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.

Complexity

  • Must be able to work in controlled/classified environments requiring special gowning. Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • Deals with plasma finished products; transfer of intermediates and products between sites/countries

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • BS degree required, preferred in a scientific or engineering discipline, with minimum of 5 years of experience in Quality, Aseptic Manufacturing (preferably with a strong focus on fill/finish operations) or related field in the pharmaceutical industry. 
  • 3-5 years of management experience.
  • Demonstrate the Takeda Leadership Behaviors; be positive, accountable, and be an excellent manager of self and others.

Location and Salary Information: This job posting excludes CO applicants

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0037023
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