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Quality Risk Management Leader

応募 後で応募 求人ID R0012483 掲載日 09/19/2019 Location:Cambridge, Massachusetts

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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 Greater Boston, MA 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 Quality Risk Management 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 will apply subject-matter expertise and operational ability to the management of an integrated  QRM program which that satisfies all applicable standards for pharmaceutical development, production, and Quality assurance and that enables continuous improvement. 

The Quality Risk Management (QRM) Leader will be providing direct support and mentoring to our Sites and operating units in order to promote understanding and adoption of risk-based approaches, build QRM capability within the business, and ensure that risk management activities comply with internal standards and health authority expectations

ACCOUNTABILITIES

  • Provide subject-matter expertise and consultation to risk management teams at the site and/or operating unit level
  • Personally facilitate complex or highly cross-functional assessments (on a selected basis)
  • Work to ensure that risk-based approaches are embedded into the relevant elements of the Pharmaceutical Quality System and that these approaches are aligned with Takeda’s global standards as well as regulatory expectations
  • Manage the escalation and reporting of risk information to management and support the continuous improvement of Takeda’s risk reporting processes.
  • Develop and deliver training on QRM concepts, methods and regulatory expectations
  • Cultivate a network of trained QRM practitioners within the sites and operating units
  • Promote the development of a risk-aware culture at Takeda and ensure alignment of these efforts with Takeda’s broader Quality Culture initiatives

Leadership

  • Ability  to lead and direct change via influence rather than direct control
  • Ability to drive collaborations across functions to accomplish objectives.
  • Strong interpersonal skills and the ability to apply these within a global, matrix organization (i.e.relationship building, listening, negotiation, and conflict management).
  • Unfailing commitment to act in accordance with Takeda’s values of  Patients, Trust, Reputation, and Business

Decision-making and Autonomy

  • Independently identifies needs, opportunities and solution approaches in the area of QRM
  • Designs and proposes solutions that address identified needs and opportunities
  • Solves moderately complex problems independently (e.g., selecting appropriate participants, method, and facilitation approach for a large-scale risk assessment)
  • Solves complex problems in consultation with supervisor (e.g., strategies for resolving misalignment among business areas with respect to risk reporting)
  • As a member of the QRM team, provides input and analysis towards the development and evolution of Takeda’s long-term QRM strategy

Interaction

  • Close, daily interaction with the QRM team
  • Frequent interaction with a broad range of QRM practitioners and stakeholders globally
  • A key focal point for QRM-related interactions across the Takeda network

    Innovation

  • Consistent with level and focused on the implementation of the QRM strategy

    Complexity

  • See “Decision-making and Autonomy” (above)

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Required:

  • Bachelor’s or graduate degree in a scientific or engineering discipline
  •  (BSc, MSc, PhD), with at a minimum of 7 or more years’ experience in the pharmaceutical, biopharmaceutical, medical device, or related industry, working within or supporting a GxP-regulated function.
  • Strong knowledge and proven experience in applying risk management tools and methods (e.g., FMEA, PHA, Risk Ranking and Filtering, Risk) in a pharmaceutical
  • A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry relevant to QRM and the operation of a Pharmaceutical Quality System
  • Demonstrated ability to collecting and synthesize  relevant data and information to enable timely, data-driven decision making
  • Fluent in spoken and written English.  Demonstrated ability to write clearly and concisely
  • Ability to balance multiple assignments in a very fast-paced environment
  • Ability to travel up to 15% for business (domestic and international)

Preferred:

  • Advanced degree in a scientific or engineering discipline
  • History of active participation within pharmaceutical industry organizations (e.g., PDA, ISPE) in the area of Quality systems and/or QRM

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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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