- Provide Quality Assurance leadership to assigned Global Development Teams throughout the compound development cycle, linking with regional Quality Assurance Compound Support teams.
- Manage the development of assigned Quality Assurance compound support strategies for compounds in development in two or more regions.
- Participate in Quality Assurance oversight of global vendors and alliance partners.
- Conduct in-licensing and acquisition due diligence assessments as assigned.
- The scope of this position includes quality management of PDD compound development activities in the TDC Asia, TDC Europe, TDC US, and JpDC regions.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Provide Quality Assurance leadership to assigned Global Development Teams, linking with regional Quality Assurance Compound Support teams in to analyze audit program results, quality issues and investigations, and batch record review. Inform Global Development Teams of development program risks and mitigation strategies. Ensure that development activities conducted by PDD and all associated sites and suppliers world-wide are conducted in compliance with Good Clinical Practice (GCP) regulations, Good Manufacturing Practice (GMP) regulations, bioanalysis regulations and guidances, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.
- Manage the development of Quality Assurance risk-based compound support plans for assigned compounds, collaborating with regional Compound Support teams to ensure that GxP compound support strategies are clearly defined and executed within the timeframes established by the plan. Link regions.
- Lead Quality Assurance Compound Review meetings with regional Compound Support representatives for assigned compounds. Evaluate progress against compound support plans. Identify and escalate key risks to development programs.
- In collaboration with regional Compound Support teams, Quality Systems, and Quality Services, develop compound-specific metrics score cards for Global Development Teams, identifying key compliance risks and developing mitigation strategies.
- Manage global Regulatory Readiness activities for assigned development compounds. Provide on-site support inspection support as needed.
- Conduct due diligence assessments of prospective in-licensing opportunities and acquisitions to identify key quality assurance and compliance risks. Conduct document reviews and on-site assessments as required.
- In collaboration with regional Compound Support teams and global Compound Support leadership, develop, implement, and update standard practices for Quality Assurance activities supporting compound development.
- Collaborate with Quality Services and Quality Systems functions to ensure that key goals and priorities are appropriately aligned.
- Monitor compliance issues and investigations across development programs for assigned compounds. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution across PDD.
- Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures. Provide appropriate risk analysis for key stakeholders to make critical decisions.
- B.S. in Science, Nursing, or related scientific field. M.S. preferred.
- 10 years of applicable pharmaceutical drug development experience with at least 6 years of GxP-related Quality Assurance experience.
- GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines.
- 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 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 and is familiar with 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 and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.
- 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.
- Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
- 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.
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
- Requires approximately 50 % travel.
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