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 Asc Dir of System Audits in our Boston office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Asc Director of System Audits working on the R&D Quality team, you will be empowered to serve as a strategic GCP quality resource to the Vaccine Business Unit (VBU) for its vaccine activities and a typical day will include:
Ensure that vendor, facility and system audits are conducted, and communicate any critical compliance risks noted from these activities to Quality Assurance senior management and ensuring that corrective actions are implemented.
Collaborate with other Quality Units and VBU functional areas to ensure that clinical trial activities in VBU are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.
Plays a leadership role in ensuring that supplier system audits at VBU are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
Responsible to implement a strategic audit plan for Vendor Audits in VBU. Ensure that activities are conducted and reports written according to applicable regulations and Takeda SOPs.
Plan and conduct/outsource domestic and international audits of Vendors (clinical, bioanalytical), and internal systems to assure compliance with local regulations, ICH and Takeda policies and procedures. With support from supervisor, assess impact of audit findings on subject safety, data integrity, and business operations.
As assigned, review and approve audit reports submitted by contract auditors for content, format, regulatory risks, and compliance with SOPs. Promote consistent audit report writing standards.
Enter audits into the Takeda QA database.
Obtain audit responses from VBU functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and Takeda policies. Escalate inadequate audit response to VBU QA management.
Lead investigations into quality issue, scientific misconduct and/or serious breach of GCP. Analyze investigation findings to identify root/probable cause. Propose, document (in the Takeda QA database), and track appropriate corrective actions. Assure reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
Participates in systems monitoring and process improvement initiatives that enhance regulatory compliance and VBU Clinical QA operating efficiency.
Manage audit teams, including outside contractor auditors, to assure compliance with objectives of this position.
Report metrics associated with assigned compounds to QA management, clinical development clinical development staff, and contract research organization staff. Evaluate if corrective and/or preventative actions are required and monitor implementation.
Identify potential systemic compliance risks, through audit activities and data analysis, and elevate to immediate manager for immediate and long-term resolution across VBU.
Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of VBU research for timely product applications to regulatory authorities. Independently analyze and interpret regulatory requirements as they apply to functional responsibilities.
Contribute to the development, introduction and continuous improvement of QA systems and processes.
Demonstrate and maintains proficiency in the knowledge and application of industry standards.
Supports inspection readiness programs and Health Authority Inspections
Minimum 8 years of experience in the pharmaceutical clinical research and development experience
Minimum 6 years of experience in clinical quality assurance experience required.
Knowledge and Skills:
In-depth knowledge of the applicable GXP regulations, Good Clinical Practices, ICH Guidelines, Regulations and Guidances and Computer System Validation
Manage internal Quality processes to assure timely identification, investigation and resolution of issues, effective risk management, and communication.
Auditing Knowledge: Demonstrates knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
Product Knowledge: Understands the medical/therapeutic impact of products.
Demonstrated analytical skills with strong attention to detail.
Scientific Knowledge: Possess the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
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 able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
Organizational skills: Must be able to prioritize work effectively to meet timelines.
Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
Strong computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables
Ability to drive to or fly to various meetings or clinical sites, including overnight trips. Some international travel may be required.
Requires approximately 20 % 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