- Provide leadership and influence to the Takeda Clinical Supplier Quality Program Managers and partner with key stakeholders that are integral to the management of outsourced clinical development activities.
- Ensure external suppliers meet Takeda quality standards.
- Ensures clinical, bioanalytical, pharmacovigilance, and R&D marketed product supplier audits are conducted in accordance with Takeda requirements.
- Serve as a strategic GCP or GVP quality resource providing GCP or GVP technical guidance recommendations to suppliers or Takeda functions responsible for managing supplier oversight.
- Develop and maintain a global supplier management plan, utilizing a risk-based approach to selecting suppliers for audit. Partner with Supplier Quality Program Manager to ensure audits are performed and reported in accordance to plans.
- Analyze supplier audit program results, quality issues, and investigations in order to optimize global operations and overall global state of compliance. Identify key compliance risks and develop mitigation strategies. Ensure that activities are conducted and reports written according to applicable SOPs, regulations, and agreements.
- Provide quality assurance leadership to Quality and drug development teams as it related to global supplier management. Act as a quality resource with expertise in regulations relating to GCP, ICH guidelines, Good Pharmacovigilance Practices, and Takeda SOPs.
- Assist in the coordination of Quality Management Working Group Meetings with key vendors, as applicable.
- Determine acceptability of suppliers for potential use by Takeda. Evaluate strategic partner and suppliers across development programs, R&D marketed products, and pharmacovigilance (PV).
- Manage individual consultant auditors to ensure that all audits, resultant reports and other work product are of acceptable quality and in compliance with Takeda requirements.
- Provide management to the global consultant auditors to identify, select and train new consultant auditors and provide management to the overall strategy for consultant auditor re-assessment.
- Develop supplier key performance indicators. Monitor performance/compliance issues identified across vendors. Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution across Takeda.
Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures related to clinical, PV, and bioanalytical suppliers. Provide appropriate risk analysis for key stakeholders to make critical decisions.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Knowledge and Skills:
- In-depth knowledge of the interpretation and application of FDA and international clinical trials regulations and guidance, and ICH Good Clinical Practice guidelines.
- Knowledge of global Good Pharmacovigilance Practices (GVP)
- Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
- Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
- Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
- Product Knowledge: Understands the medical/therapeutic impact of products.
- Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology, standards of care, and disease states.
- Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
- 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.
- 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. Must be proficient in use of the Quality Assurance Audit Database (QAAD).
- ASQ Certified Quality Auditor (CQA) or SQA Registered Quality Assurance Professional certification preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires up to 50% travel.
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