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 Global Patient Safety Evaluation Quality in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Head working on the Global Patient Safety and Evaluation Quality Assurance team, you will be empowered lead and optimize the Global Patient Safety and Evaluation Quality Assurance (GPSE QA) organization, and a typical day will include:
- Provide quality assurance oversight of Takeda Pharmacovigilance and of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPVP) activities conducted by Local Operating Companies (LOCs).
- Define and articulate the strategy for GPVP and LOC GCP oversight, in close collaboration with the Global Patient Safety Evaluation, Global Medical Affairs, and Commercial Quality functions.
- In close collaboration with R&D Quality Compliance and Systems, ensure that all processes implemented by GPSE and LOC medical functions meet or exceed regulatory requirements, industry standards, and Takeda requirements.
1. Responsible for quality oversight of the global pharmacovigilance system.
2. Lead and optimize the GPSE QA 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 Compliance and Systems.
- Direct interactions with regulatory agencies related to GPVP compliance issues.
3. Define and articulate the strategy for the overall philosophy, scope and key elements of oversight of GCP and GPVP 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.
4. In collaboration with Quality Compliance and Systems, progress and maintain the procedural documents that support GPVP-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.
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
- Expert knowledge of Good Pharmacovigilance Practice (GPvP) requirements for clinical trials and marketed products. Strong working knowledge of GCP requirements.
- Experienced in hosting/leading clinical health authority inspections.
- Proficient in analyzing data to identify performance trends.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Proven ability to proactively identify and lead the development and re-engineering of key processes and systems in support of the business s mission.
- Highly effective communicator who is capable of establishng a compelling vision for GPSE QA.
- Sets strategy for GPSE QA.
- Outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view.
- Clear, concise, and consistent in written and verbal communications.
- Ensures that every employee knows what is expected of their role and what it takes to be successful, and how they are progressing. Holds employees accountable to achieve results while demonstrating Takeda s values and strategic priorities of Patient, Trust, Reputation, and Business.
- Helps employees grow through challenging opportunities so that they may realize their full potential.
- Serves as a role model for being brave and taking appropriate risks, always in compliance with clinical trial regulations and Takeda requirements.
Decision-making and Autonomy
- Manages within the department budget established for PVQA, and empowered to make hiring decisions within allotted headcount.
- Makes organizational design decisions in alignment with the Head of R&D Quality.
- Experience working within complex organizations, working closely with senior staff and executive level colleagues. The ideal candidate will have the acumen to handle complex situations and multiple responsibilities simultaneously mixing long term projects with the urgency of immediate demands on the operations. S/he must also have the demonstrated ability to deal with highly confidential information and act as a liaison between Head of R&D Quality and other executives.
- Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal/regulatory documents.
- Effectively presents information to senior management, internal groups, external stakeholders and customers.
- Leads oversight of the global pharmacovigilance system, requiring effective cross-cultural working skills and expert knowledge of GPvP requirements across health authorities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA degree and advanced degree preferred.
- Expert knowledge of global pharmacovigilance system requirements. Strong working knowledge of GCP requirements.
- Minimum of 12 years of industry experience in Quality Assurance or related field, with majority of experience in pharmacovigilance systems.
- Professional certification/registration preferred
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- 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.
No Phone Calls or Recruiters Please.