- Lead and optimize the Takeda Global Research and Development (TGRD) Quality Assurance Function for the Americas region, including Canada, the United States, and Latin America.
- Define, direct, and articulate the strategy for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance oversight for TGRD Americas.
- Ensure that all TGRD Americas quality systems meet or exceed regulatory requirements and industry standards established by FDA and other regulatory agencies, and by the ICH.
- Report (solid line) to the Head of Global Development Quality Assurance, and is a member of the Pharmaceutical Development Division Quality Governance Committee. Report (dotted line) to the President of TGRD Americas, and is a member of the TGRD Americas Executive Team.
Define and articulate the strategy for the overall philosophy, scope and key elements of TGRD America’s oversight of GCP and GVP activities, including but not limited to training, SOPs, auditing, project support, CAPA management, vendor/CRO quality management, compliance oversight, and regulatory intelligence.
- Safeguard development pipeline by ensuring that TGRD development projects progress through development phases in a compliant fashion such that compliance issues will not result in failure to approve.
- Direct staff and systems responsible for monitoring the TGRD’s adherence to quality assurance programs, policies, processes, procedures and controls and ensuring that all clinical trial and pharmacovigilance activities performed by TGRD Americas are in compliance with TPC and TGRD standards, policies and procedures and all applicable regulations.
- Direct TGRD staff involved in managing regulatory inspections and inspection readiness preparation.
- Direct interactions with FDA and other regulatory agencies related to compliance issues.
- Direct TGRD Americas QA compliance consultation activities for Takeda operational functions.
Create and maintain a quality culture of transparency and efficient communication of quality related matters to achieve and maintain the desired high state of quality across TGRD Americas development operations.
- On an ongoing basis understand, communicate, and mitigate compliance risk.
- Establish regional escalation process for TGRD Americas to ensure transparency and timely reporting of urgent/important issues.
- Working with PDD QA and both internal and external partners, establish and monitor Quality goals and KPIs.
- Works with the Compliance Officer in Takeda Pharmaceuticals U.S.A. (TPUSA) to ensure execution of compliance programs related to United States Office of the Inspector General (OIG) and legal compliance matters for TGRD Americas employees.
In collaboration with PDD Quality Systems, progress and maintain the PDD QMS, including the development and maintenance of quality standards that are compliant with global regulatory requirements, aligned with Takeda and R&D policies, and contemporary with industry trends and best practices.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
- Drive strategies for processes, standards, and systems that minimize compliance risk and operational inefficiencies and maximize a strategic level of standardization.
- Promote quality and the compliance mindset of employees and management by communicating, regulatory trends, regulatory and TGRD’s compliance challenges and strategies
- Ensure resources for TGRD Americas QA are adequate to fulfill quality and compliance strategies and goals.
- Ensure all relevant elements of TGRD America’s Quality Systems evolve to support PDD and TGRD organizational or functional changes as well as changes in the global regulatory environment.
- Direct staff and systems that ensure timely and thorough completion of corrective and preventative action responses to audit findings and other quality issues.
- Direct staff tasked with interpreting evolving governmental regulations and agency guidelines and ensures standards and procedures assure compliance.
- Bachelor of Science degree required.
- Master of Science or other advanced degree (MD, PhD, PharmD) preferred.
- 15 years of increasing responsibility in the pharmaceutical industry
- 10 years experience in Quality Assurance
- 8 years of progressive management experience
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
- Proven track record in managing global, cross-functional projects
- Regulatory Knowledge - Expert knowledge of global GCP and GVP regulations and guidances; good working knowledge of global GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
- Industry Knowledge – Strong working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used to execute a clinical development program.
- Demonstrates advanced knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
- In-depth understanding of the good practices for the creation and management of a Quality Management System.
- Scientific Knowledge - Possesses the necessary science education and knowledge to provide Quality Assurance oversight of 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, both verbally and in writing. Must demonstrate professional presentation skills.
- Negotiation Skills - Demonstrates proficiency in negotiation and conflict resolution.
- Personnel Management Knowledge – Proficient in managing large teams, and in providing coaching and mentoring to employees.
- Project Management - Demonstrates 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, and delegate to subordinates.
- 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.
- 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 drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
- Requires approximately 40 % travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 10 months ago