Global Regulatory Affairs, Quality Management Systems Manager - United States
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 Global Regulatory Affairs, Quality Management Systems Manager in our Cambridge MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Global Regulatory Affairs, Quality Management Systems Manager working on the Global Regulatory Affairs team, you will be empowered to be innovative and drive the overall GRA Training Program, and a typical day will include:
- Supports the GRA Quality Management System (QMS) in ensuring that the processes, procedures and effectiveness of the GRA QMS are implemented and compliant to applicable global regulatory requirements.
- Responsible for the ongoing maintenance and support of the global Quality Management System (QMS).Acts as subject matter expert and project lead for multiple projects to drive continuous improvement of systems.
- Facilitates the GRA QMS process 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, quality event and deviation management, audit and inspection management and QMS continuous improvement projects.
- 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. Ensures internal review of QMS documents from other functional areas
- Analyzes and communicates compliance metrics, ensuring communication of oversights. Make recommendations of quality improvements across GRA.
- Manages overall GRA Training program ensuring development and delivery of training materials describing system related business processes.
- 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 interface with all disciplines in the identification and understanding of the interfaces between the different functions in respect to QMS.
- Maintains awareness of QMS, lead communication efforts to global RA persons on changes/updates to the QMS
- Updates and manages QMS information/access sites/portals
- 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, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree (or equivalent) required. Masters preferred.
- 5 + years experience in Pharmaceutical industry, with 3-5 years in Regulatory Affairs, research and development or quality assurance/compliance.
- A minimum of 3 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.
- 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.
- Routine demands of an office based environment.
- 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
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.