|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.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- B.S. in Biology, Nursing,
Pharmacy, or related scientific field.
- Minimum 12 years of
increasing responsibility in pharmaceutical,GCP-
and/or GPvP related Quality environment.
- Minimum 10 years of people
and/or process management experience in GCP and/or GPvP Quality Assurance
including senior level project planning/budget management.
5 years of progressive matrix management experience, and extensive
experience leading a team dispersed in multiple, global locations.
in managing complex organizational compliance issues and in identifying
and implementing organization-wide compliance initiatives
in managing global, cross-functional projects
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.
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.
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
understanding of the good practices for the creation and management of a
Quality Management System.
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.
Skills - Must professionally, clearly, concisely and consistently
communicate to external and internal customers, both verbally and in
writing. Must demonstrate
professional presentation skills.
Skills - Demonstrates proficiency in negotiation and conflict resolution.
Management Knowledge Proficient in managing large teams, and in
providing coaching and mentoring to employees.
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.
Skills - Must be able to prioritize work effectively to meet timelines,
and delegate to subordinates.
- Must be able to adapt to other personalities in a respectful manner that
is conducive to goal achievement and team building.
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.
- Six Sigma Green Belt or
Black Belt preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
WHAT TAKEDA CAN OFFER YOU:
- Position is located in Boston.
- 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
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.