Senior Program Manager/Program Manager Quality Systems
February 5, 2018
Full Time - Experienced
4 Year Degree
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 Program Manager/ Program Manager Quality Systems in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Program Manager/ Program Manager Quality Systems working on the Research and Development Quality Systems team, you will be empowered to lead Takeda Global R&D US functional teams in the identification and mitigation of systemic issues which may compromise the compliance of Takeda’s drug development operations, and a typical day will include:
The person in this position will work with R&D Quality Assurance and global project teams in the quality investigation, deviation and waiver process including root cause analysis, remediation, tracking and documentation including driving efficiencies across organization. This position works closely across multiple functional areas to drive the mitigation of compliance risks identified internally through CAPAs and deviation programs, and those identified through the Quality Systems Regulatory Intelligence process. This position influences and defines the support required to support Quality Systems and regulatory inspections as needed.
Lead R&D US functional area teams as quality investigation, deviation and CAPA liaison when quality issues, posing potential compliance risks to Takeda are identified. Advise teams on activities required to mitigate risk.
Utilizing standard quality management tools, conduct root cause analysis of issue and identify tasks for remediation including process improvement.
In conjunction with R&D US functional area teams, assign responsibilities for remediation tasks and due dates.
Manage/Report and monitor progress of identified gaps and align business requirements as needed to meet compliance and business needs.
Assess compliance success and develop tools to ensure applicability with functional teams as needed to reduce current and future regulatory and compliance risk.
Align improvements made under quality investigation and CAPA programs across existing systems, procedures, and policies.
Drive timely execution of quality investigation and CAPA deliverables through monitoring and reporting activity status to functional area and QA management.
Innovate with management, peers and subordinates to assess and improve the adequacy of the quality investigation and CAPA processes.
Knowledgeable regarding regulations, laws and standards to maintain Takeda process compliance.
Partner with Global Quality Systems and global Quality Systems to formulate plans to interpret industry regulations, guidelines and internal policies to assure compliance.
Manage, execute and deliver quality investigation & CAPA process training as required to ensure the appropriate level of process knowledge is maintained throughout organization.
Support regulatory authority inspections as needed.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors degree required; advanced degree preferred Minimum 8 years Quality assurance experience in pharmaceutical industry or related health care industry.
Minimum 5 years working knowledge of Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidance’s and Computer System Validation.
Development: Extensive knowledge of, processes and techniques used to execute a clinical development program.
Science Knowledge: Possess the necessary science education and knowledge to understand GxP issues related to clinical trials and marketed products.
Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be proficient in the necessary professional presentation skills, deliver fair/-balanced presentations and, when applicable, facilitate resolution of differing opinions.
Project Management: Must be able to manage all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
Organizational skills: Must be highly flexible and able to prioritize work effectively to meet timelines.
Interpersonal: Must be highly adept at adapting to other multi-cultural/ personalities in a respectful manner that is conducive to goal achievement and team building.
Experience with quality tools and process improvement techniques
Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
Approximately 10-15% travel.
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
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
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 space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.
While Takeda is enjoying trem...endous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!