Ensures clinical, bioanalytical, pharmacovigilance (PV), and R&D marketed product supplier audits are conducted in accordance with Takeda requirements.
Ensure external suppliers meet Takeda quality standards.
Develops and maintains a global supplier audit schedule.
Manages the global consultant auditor process, including identifying and managing the ongoing performance of auditors as well as the audit process.
- In collaboration with Clinical Quality Assurance and Pharmacovigilance Quality develop supplier management oversight and auditing strategy on a global basis.
- Develop and maintain a global supplier management plan, utilizing a risk-based approach to selecting suppliers for audit.
- 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.
- Determine acceptability of suppliers for potential use by Takeda. Evaluate strategic partner and suppliers across development programs, R&D marketed products, and 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.
- 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 and bioanalytical suppliers. Provide appropriate risk analysis for key stakeholders to make critical decisions.
- Provide quality assurance leadership to drug development teams as it related to global supplier management. Act as a quality resource with expertise in regulations relating to GCP, ICH guidelines and Takeda SOPs.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education & Experience:
- B.S. in Science, Nursing, or related scientific field.
- 5 years of applicable pharmaceutical drug development/clinical/pharmacovigilance experience with at least 3 years of GCP or GVP related Quality Assurance experience.
- Minimum 3 years of quality assurance auditing experience
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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