QRM Leader


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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Risk Management Lead in our Cambridge, MA or Vienna, Austria office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.

As a QRM Leader, you will be a vital contributor to our inspiring, bold mission. A typical day will include:

OBJECTIVES/PURPOSE

The Quality Risk Management (QRM) Leader is responsible for providing systematic and operational expertise to the management of a comprehensive and integrated risk management program which meets applicable internal and external standards for drug, device and biologics manufacturing.

The QRM Lead will be key to the success of the Quality Risk Management program and will provide direct support and mentoring to our Sites and OpUs to ensure appropriate execution of the Risk Management program.The position will support the Takeda network to provide proper guidance and to ensure risks associated with our Operations and Systems are handled with a Risk based approach to allow for greater opportunity for process control and process improvement.

ACCOUNTABILITIES

  • Provide training and development support to the Takeda network with respect to the Quality Risk Management program
  • Co-ordinate and facilitate complex or cross-site/ cross-product risk management efforts for  sites and products when appropriate
  • Provide Technical Expertise to the Risk Assessment teams at the Sites supporting projects including the installation, operation, maintenance of Site equipment and production utilities
  • Escalation and communication of risks through the appropriate pathway to ensure visibility to Management.
  • Implementation of business processes for integration of Quality Risk Management into relevant elements of the Pharmaceutical Quality System
  • Supporting the development of the QRM Training Program and provide guidance / training to our Takeda’s appointed personnel
  • Assist with the development of training curriculum in support of developing a QRM culture across Takeda
  • Provide Risk Management expertise on complex technical problems
  • Facilitate Quality Risk Management workshops, brainstorm/rapid results events, and work with employees across the organization to enable them to do the same
  • Promote a culture of Quality Risk Management
  • Strong leadership and effective interpersonal skills particularly motivational, negotiation, listening, judgement and conflict management skills as is demonstrated in a matrix global environment.
  • Proven leadership capability and effectiveness in ability to work well with cross-functional teams to accomplish objectives.
  • Demonstrated leadership and capability to work effectively in a fast paced rapid changing technology environment and to work on multiple work streams and projects simultaneously
  • Excellent organization, written, and verbal skills to convey global project goals and inspire support from both subordinates and senior management

DIMENSIONS AND ASPECTS

  • Solid understanding of the pharmaceutical industry
  • Proven experience in application of Quality Risk Management tools and methodologies such as: FMEA, PHA, Risk Ranking and Filtering, Risk reporting, etc.
  • Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed
  • Must be able to make and implement quality decisions
  • Profound knowledge and experiences with Quality Management and systems in a regulated industry
  • Structured in communication and presentation to senior management

Leadership

  • Proven ability to lead by directing change as well as by influence on areas not within direct control.
  • Lead and drive collaborations with cross-functional teams to accomplish objectives.
  • Independent global leadership to work effectively in a fast paced rapid changing technology environment and to work on multiple work streams and projects simultaneously
  • Lead and routinely demonstrate strong interpersonal skills particularly motivational, negotiation, listening, judgment and conflict management skills as is demonstrated in a matrix global environment.
  • Enable Takeda to deliver on its commitment to Patients, Trust, Reputation, and Business

Decision-making and Autonomy

  • Responsible for Quality Risk Management deployment and coaching that impact Manufacturing and Development
  • Responsible for assuring internal Quality Risk knowledge development is fully compliant with external regulations

Interaction

  • Key interactions across manufacturing and development network
  • Key focal point for cross functional collaborations internal to Takeda
  • Domestic and international travel up to 20% for business needs in QRM deployment and facilitation.

Innovation

  • A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry
  • This role will be principle to engaging cross functionally to assure Takeda is advancing innovation for a Quality advantage.

Complexity

  • This global role is principle to develop and sustain the Quality Risk Management Program that is “fit for purpose” to support the broad range of established and innovative product lines and augment capabilities within the Takeda organization.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Scientific or engineering graduate (BSc, MSc, PhD), with at a minimum of 7 years’ experience in the pharmaceutical, biopharmaceutical, medical device, or related industry.
  • Experience with Facility and Operations evaluations through application of Quality Risk Management tools and methodologies such as: FMEA, PHA, Risk Ranking and Filtering, Risk reporting, etc.

Desired:

  • Experience must include successful examples of managing global change by influence - without direct resource control;
  • Strong focus on delivering global results as well as building site capability to demonstrate effective governance
  • Fluent in written and spoken English

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

    Empowering Our People to Shine

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

Locations

Cambridge, MA

Vienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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