Posted to MedZilla HealthCare on 1/23/2018


Takeda Pharmaceuticals

US-MA, Manager, Global Regulatory Affairs, Quality and Compliance 1800085-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Manager / Manager, Global Regulatory Affairs, Quality and Compliance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager / Manager working on the Global Regulatory Affairs Quality and Compliance team, you will be empowered to be collaborative and innovative, and a typical day will include:

POSITION OBJECTIVES:
  • Responsible for the ongoing maintenance and support of the GRA Global Quality and Compliance Systems, ensuring overall compliance and effectiveness of the GRA quality system.
  • Program Management of key GRA Quality and Compliance initiatives that drive continuous improvement of the GRA and Takeda systems.
  • Facilitates the GRA Quality Management System (QMS) to reach harmonized and streamlined processes which meet business needs. Ensures that personnel are aware and responsive to external guidelines and regulations as they pertain to quality management and compliance.
  • Coordinates and participates in audits and inspections in GRA globally.
  • Supports the monitoring, measurement and effectiveness of all GRA QMS processes including but not limited to; training, procedure management, change control, quality event and deviation management, audit and inspection management and QMS continuous improvement projects.
POSITION ACCOUNTABILITIES:
  • Performs and supports project leaders through the program management of key GRA Compliance and Quality Systems initiatives.
  • Works to ensure compliance for the Regulatory Organization, including internal and external teams and partners.
  • Participates in the creation, review, approval and lifecycle management of controlled quality documents (e.g. SOPs) and supporting documents within Global Regulatory Affairs.
  • Plans and ensures end-user training is conducted globally and locally. Ensures appropriate assignment and management if individual training matrices within GRA.
  • Manages Quality Event Investigations and deviations in collaboration with relevant stakeholders establishing effective and timely CAPAs
  • Partners with R&D QA and interfaces with other Takeda disciplines in the identification and management of global initiatives.
  • Participates in global projects for QMS development and maintenance
  • Develops and analyzes compliance metrics, and identifies potential improvement activities. Communicates issues/trends to Compliance management.
  • Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GVP and GCP
  • Leads/supports GRA in Inspections and audits covering readiness activities, fulfilment of requests and the management of any outcomes
  • Develops and maintains the GRA Business Continuity Strategy and plan in collaboration with the Leadership and QMS team
  • Supports overall regulatory intelligence efforts to ensure GRA maintains overall compliance to new and revisions to Global regulatory requirements as they impact GRA.

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:


Education and Experience Required:

  • Bachelor s degree (or equivalent) required. Masters preferred.
  • 5 + years experience in Pharmaceutical industry, with 2-3 years in Regulatory Affairs, research and development or quality assurance/compliance.
  • A minimum of 5 years of QMS experience. Experience in the development, implementation and maintenance of a QMS is recommended
  • Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
  • Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets.
  • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
  • Ability to work independently and focus on multiple issues/deadlines simultaneously.
  • Ability to critically analyze complex and/or ambiguous information and the impact on products and process.
  • Ability to effectively communicate complex issues both verbally and in writing.
  • Excellent analytical, technical and problem solving skills (TQM or Six Sigma experience preferred.
  • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.

Skills and Knowledge Desired:

  • Systems Knowledge extensive knowledge of Quality Management Systems
  • Regulatory Familiarity extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs
  • Industry Knowledge strong understanding of the pharmaceutical industry and pharmaceutical companies operations processes and strategies including Regulatory Affairs processes.
  • Takeda Operations in-depth understanding of Takeda s operating philosophy, structure and methods including a thorough knowledge of the foreign owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department.
  • Analytical Skills ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
  • Communication ability to express oneself clearly and concisely to a variety of audiences
  • Team Working - Ability to work with team members in a friendly, professional manner.
  • Knowledge Sharing ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use.
  • Interpersonal Flexibility ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
  • Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization.

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.

TRAVEL REQUIREMENTS:

  • 10%, some international required.

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


Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-ND1


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.