Head, Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance
January 3, 2018
Full Time - Experienced
4 Year Degree
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 Head of Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Head of the Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance team, you will be empowered to lead the function, and a typical day will include:
Lead and optimize the Pharmacovigilance Quality Assurance function and LOC Medical Quality Assurance function, with quality assurance oversight of Takeda Global Patient Safety Evaluation and of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) activities conducted by Local Operating Companies (LOCs).
Define and articulate the strategy for GVP and GCP (at LOCs) oversight, in close collaboration with the Global Patient Safety Evaluation, Global Medical Affairs and Commercial Quality functions.
In close collaboration with R&D Quality Systems and Compliance, ensure that all processes implemented by Pharmacovigilance and LOC medical functions meet or exceed regulatory requirements, industry standards, and Takeda requirements.
Report to the Head of Research and Development Quality, and serve as a member of the Research and Development Quality Leadership Team (RDQLT).
Lead and optimize the Pharmacovigilance Quality Assurance function, ensuring that the PV activities for all Takeda development compounds and marketed products are conducted in compliance with regulatory requirements and industry standards:
Direct staff and systems responsible for monitoring the adherence to quality assurance programs, policies, processes, procedures and controls and ensure that all Takeda pharmacovigilance activities conducted in pharmacovigilance hubs and in LOCs are in compliance with Takeda policies, standards, and procedures and all applicable regulations.
Direct global PV inspection activities, including inspection preparation and inspection management, in close collaboration with R&D Quality Systems and Compliance.
Direct interactions with regulatory agencies related to GVP compliance issues.
Develop a close collaboration with Global Patient Safety Evaluation to drive performance improvement within Takeda, at Takeda’s suppliers, and at Takeda’s business partners.
Define and articulate the strategy for the overall philosophy, scope and key elements of oversight of GCP and GVP activities conducted in LOCs, in alignment and close collaboration with Commercial Quality, including but not limited to training, audits, vendor/CRO quality management, compliance oversight, and regulatory intelligence.
Ensure that progress through development phases in a compliant fashion such that compliance issues will not result in failure to approve.
Direct compliance consultation activities.
Ensure that the LOC audit program effectively identifies gaps and risks in the LOC’s quality management system for GCP- and GVP-regulated activities.
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:
On an ongoing basis understand, communicate, and mitigate compliance risk.
Establish escalation process for Global to ensure transparency and timely reporting of urgent/important issues.
Working with and internal and external partners, establish and monitor Quality goals and KPIs.
In collaboration with R&D Quality Systems and Compliance, progress and maintain the procedural documents that support GVP-regulated activities (across Takeda) and GCP-regulated activities (at the LOCs) including the development and maintenance of quality standards that are compliant with global regulatory requirements, aligned with Takeda and Global Quality requirements, and contemporary with industry trends and best practices.
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 compliance challenges, and strategies to identify and address gaps.
Ensure resources are adequate to fulfill quality and compliance strategies and goals.
Direct staff and systems that ensure timely and thorough completion of corrective and preventative action responses to audit findings, inspection commitments, and quality issues.
Direct staff tasked with interpreting evolving governmental regulations and agency guidelines and ensure standards and procedures assure compliance.
In collaboration with R&D Quality Services and Improvement, identify and communicate needs within supported functions for process improvement. Engage R&D Quality Services and Improvement to lead and support Operational Excellence initiatives such as Six Sigma and Kaizen events.
Bachelor of Science degree required.
Master of Science or other advanced degree (MD, PhD, PharmD) preferred.
Minimum 15 years of increasing responsibility in the pharmaceutical industry
Minimum 8 years experience in Quality Assurance, with minimum 3 years leading a pharmacovigilance quality assurance function.
Minimum 3 years supervising GCP- and GVP-regulated activities at LOCs and equivalent affiliate companies.
Minimum 5 years of progressive management experience, and extensive experience leading a team dispersed in multiple, global locations.
Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
Skilled 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 or equivalent preferred.
Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest spac...e at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.