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 Quality Systems Senior Program Manager/ Program Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Systems Senior Program Manager/ Program Manager 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
- 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.
No Phone Calls or Recruiters Please.