Associate Director, Quality Assurance Audit & Pharmacovigilance Business Partner (Remote)

Company: Takeda
Location: Boston
Posted on: March 21, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Associate Director, Quality Assurance Audit & Pharmacovigilance Business PartnerLocation: Cambridge, MA (Remote)OBJECTIVES/PURPOSE:

• Contributes tostrategic quality oversight activities of PV business partners and suppliers that promotes operational and compliance excellence, quality risk management and knowledge management
• Experience in pharmacovigilance and quality management system auditing, project management and operational knowledge of an audit program and management of the day-to-day priorities of the BPSQA audit program by problem solving, addressing complex challenges, identifying risks, escalating issues to senior management, communicating expectations to internal and external stakeholders, and onboarding junior staff while understanding Takeda's business priorities and needs with the business partners and suppliers
• Conducts end-to-end audit operations and ensures the timely and compliant execution of the BPSQA auditprogram by providing pharmacovigilance and quality assurance expertise
• Support partnerships with internal stakeholders, understanding Takeda's business priorities and needs with the business partners and suppliers and communicating actionable insights from the BPSQA audit program and vendor quality management and oversight forum
• Reports to the Head of BPSQA and contributes to the development and implementation of BPSQA audit programAccountabilities:
  • Supports senior management with the strategic quality oversight activities of strategic business partners and suppliers through the review of controlled procedures and templates related to PV business partner and supplier oversight activities including PVAs, Quality Agreements, Quality Plans, etc., to ensure regulatory and past inspection commitments are considered.
  • Assists senior management with systemic quality event investigations relevant to business partners and suppliers that impact the pharmacovigilance system in identifying quality and compliance risks, contributing to robust investigations and assisting with adequate corrective and preventive actions (CAPAs) development, ensure continual improvement that is aligned to Takeda's values and strategic priorities in collaborate with different functions across the globe
  • Provides input across R&D Quality functions to support the consultant auditor framework, supplier qualification activities, cross functional initiatives, process improvement initiatives and participate in complex compliance projects and act as the BPSQA point of contact to consultant auditor firms
  • Executes the operational level activities for audit preparation, scheduling, audit scope, audit sampling, audit planning, audit conduct, audit response report and CAPA plandevelopment of individual PV routine, qualification and/or directed audits of businesspartners and suppliers and support directed auditsand ensure any risks are escalated the management and Head of BPSQA
  • Oversee the accuracy and management of audit data and closure of CAPAs and Effectiveness Checks within the audit management system
  • Contributes input to the strategic and tactical level BPSQA risk-based audit program and communicate the updates to the annual program and ensure any risks are communicated to the Head of BPSQA
  • Contributes to the relevant metrics and Key Performance/Quality Indicators (KPI/KQI) of the BPSQA audit program. Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely.
  • Ensure any risks are communicated to the Head of BPSQA.
  • Provides pharmacovigilance and quality assurance expertise and support inspections and business partner audit activities by engagement with internal/external stakeholders aboutinspection/audit deliverables, timely notifications, and communications and documentrequests
  • Support cross-functional continual improvements projects that enable a compliant quality systems in the pharmacovigilance systems.
  • Partners with senior management to develop audit standardized functional tools and processes (internal request documents, audit plans, audit agenda and audit questionnaire templates), lead the peer review of audit report, interface with lead auditor to resolve and/or address audit report changes
  • Act as a delegate to the BPSQA LeadEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    • BSc in a scientific or allied health/medical field (or equivalent degree).
    • Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of experience in GCP/GVP Quality/Compliance.
    • Advanced knowledge of pharmaceutical development, medical affairs andGCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
    • Advance knowledge in strategic and non-strategic supplier quality oversight
    • Experience must include successful development and implementation of a pharmacovigilance audit program, hosting/leading business partner audits and remediation activities on a global level.
    • Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
    • Skilled in managing global, cross-functional projects.
    • Demonstrated proficiency in negotiation and conflict resolution with stakeholders.
    • Ability to navigate a fast-paced and dynamic environment with organization and prioritization skills to meet established timelines.
    • Fluency in written and spoken English, additional language skills a plusWhat Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Professional training and development opportunities
      • Tuition reimbursementImportant Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
        • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
        • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
        • Work in a cold, wet environment.
        • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
        • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Base Salary Range: $143,500 to $200,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.#pharmacovigilance#pv#gpv#gcp#GMSGQ#ZR1#LI-LR1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda, Boston , Associate Director, Quality Assurance Audit & Pharmacovigilance Business Partner (Remote), Executive , Boston, Massachusetts