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 the Head of Research and Development Quality Systems in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Head of Research and Development Quality Systems working on the R&D Quality team, you will be empowered to provide leadership and strategic direction for R&D Quality Systems, and a typical day will include:
Lead the three sub-functions of Quality Architecture, Documentation and Training, and Quality Performance. This role partners with the Global Quality function, R&D and R&D Quality counterparts.
Lead the global Quality professionals responsible for R&D Quality Systems located in Singapore, Boston, and Japan (Osaka).
Participates as a key member of the R&D Quality Management Team.
Provides R&D global leadership and strategic direction for R&D Quality Systems.
As both Global Quality and R&D refine the business of Quality and the R&D long-range plan, closely align all aspects of R&D Quality Systems.
Leads the R&D Quality Architecture function, and fulfils the following key deliverables:
Provides regulatory and technical expertise and leads the development of R&D procedures and supporting documents, ensuring alignment with Global Quality organizing principles and the R&D business.
Interprets new regulations and incorporates as appropriate in the R&D processes.
Ensures R&D procedures and supporting documents are aligned with Global Quality and are in a state of compliance.
Sets and maintains clear requirements for procedure format, content level, and logical document hierarchy.
Oversees the receipt, investigation, and resolution of non-medical complaints, and engages Global Patient Safety Evaluation for medically related complaints.
Ensures that regulatory and other CAPA commitments are met.
Leads investigations (excluding those relating to Scientific Misconduct) and manages deviations.
Leads the Documentation and Training function of R&D, fulfilling the following key deliverables:
Develops training strategy for R&D to promote agility and respond to the needs of an evolving R&D organization.
Ensures that training delivery methodologies are appropriate to the process or topic.
Ensures that training matrices are appropriate.
Monitors training compliance, generates metrics for R&D and R&D Quality leadership, and intervenes to improve compliance when needed.
Leads the R&D Quality Performance function, fulfilling the following key deliverables:
Provides metrics and KPIs to improve quality and promote compliance with health authority requirements and Takeda’s expectations..
In collaboration with the functional R&D Quality leads, organizes and leads functional Quality Councils.
Participates as a key member of the R&D Quality Management Team
Meeting biweekly and face to face quarterly, participates on the R&D Quality Management Team responsible for the oversight of Quality for R&D.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Minimum 15 years of increasing responsibility and experience in the global pharmaceutical industry.
Minimum 10 years of Quality/QC/Compliance experience, with minimum 4 years experience in developing and managing global Quality Systems.
In-depth understanding of global regulations governing the US and international biopharmaceutical industries. Ability to translate and articulate appropriate strategies and activities to ensure compliance to all regulations relative to quality management systems.
Minimum 5 years of managerial experience including senior level project planning.
Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels where the incumbent may not have direct authority.
Expert knowledge and experience with risk management strategies, project reporting, and general project management experience/expertise required. Proven track record in managing global teams. Experience leading and managing complex and matrix teams and processes in a global organization. Proven success in identifying and implementing organization-wide compliance initiatives.
Direct experience reporting to global, senior-level management on metrics and key performance indicators (Management Review). Ability to interpret regulatory intelligence and translate, as appropriate, into CMCC’s Quality Systems.
Experience in working with/managing with regulatory agency relationships relative to all GMP quality systems issues.
Ability to influence and work effectively with various business partnerships, regions and cultures.
Strong interpersonal skills, particularly motivating employees, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment
Excellent organization, verbal and written communication skills to explain project goals and inspire support. Must be a proactive and effective communicator.
Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance.
Demonstrated proficiency in MS Office applications required; proficiency in Quality Systems Databases such as Track Wise highly desirable.
Demonstrated ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
Must have an advanced knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory compliance information is up-to-date.
Routine demands of an office environment
Travel required, approximately 25%, domestic and international.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest spac...e at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.