Associate Director, Quality Assurance Pharmacovigilance Auditor (Remote)

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Job Title: Associate Director, Quality Assurance Pharmacovigilance Auditor

Location: Cambridge, MA (Remote)

• Provides strategic quality oversight activities to PV strategic business partners and suppliers that promotes operational and compliance excellence, quality risk management and knowledge management
• Oversees and ensures the timely and compliant execution of the BPSQA audit program, providing pharmacovigilance and quality assurance expertise
• Establishes and maintains a partnership 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 and acts as a strategic thought partner to the Head of BPSQA in developing and implementing BPSQA strategies and building capabilities within the BPSQA team and in ensuring alignment with the PV & Medical Quality vision

How you will contribute:

• Executes strategic quality oversight activities of strategic business partners and suppliers through the qualification and routine audit program, inspection support, Quality Management Working Group Work (QMWG), quality agreement, quality event investigation/deviation management and the communication of critical and major compliance risks to Head of BPSQA in compliance with Takeda procedures, policies and regulatory guidance
• Lead the preparations, conduct, reporting and follow up of the audits for strategic suppliers under PVMQ remit
• Lead the preparation and execution of the Quality Agreement for strategic suppliers
• Co-chair the Quality Management Working Group (QMWG) with strategic supplier quality partner to ensure quality assurance focused oversight the overall quality partnership, review risk associated with processes, deviations and agreed upon key quality indicators and actions.
• Facilitate systemic quality event investigations relevant to business partners and strategic/non-strategic 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
• Reports, escalates any significant compliance risks and issues to the Head of BPSQA and PVMQ Leadership Team, when necessary.
• Acts as delegate to the Head of BPSQA in the Joint Operating Committee for PV Strategic Partners, attend meetings, ensure any identified quality risks and/or gaps are reported from QMWGs
• Drives the operational activities of strategic and tactical level BPSQA risk-based audit program (i.e., update/identify risk to the annual program, assignments to junior staff, allocation of auditee candidates to consultant auditor firms, ensure qualification of auditors, monitor audit & CAPA metrics and ensure any risks are communicated to the Head of BPSQA)
• Drives and monitors the regular reporting of relevant metrics and Key Performance/Quality Indicators (KPI/KQI) for 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.
• Serve as the pharmacovigilance and quality assurance expert to review the audit language in PV suppliers’ contracts including Market Research and Patient Support Programs contracts, Business Partner Pharmacovigilance Agreements (PVAs) to ensure compliance with Takeda policies and procedures and regulatory guidance.
• Provides pharmacovigilance and quality assurance expertise and POC for internal audits, cross sub functional group audits across the RD &Quality business, inspections and business partner audit activities by the presentation of BPSQA risk-based audit program, engagement with internal/external stakeholders about inspection/audit deliverables, quality control of document requests, timely notifications, and communications and document requests
• Collaborates 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
• Provide direction to junior staff on robust audit operational activities and the development of adequate audit responses, CAPA plan, Effectiveness Checks and management review and approval of audit reports. Support junior staff with understanding complex audit findings and/or challenges with audit preparations and audit reports.
• Coaches junior BPSQA staff to support capability building and talent development through onboarding and mentoring
• Contributes as an PVQA SME for specific change control procedures involving strategic or non-strategic suppliers to ensure compliance of the change control with applicable QMS requirements, Takeda policy and procedures and regulatory guidance
• Develop lessons learned and trends from on BPSQA audits. Promotes knowledge management.
• May lead cross-functional continual improvements projects that enable a compliant quality systems in the pharmacovigilance systems.
• Review and approve controlled procedures and templates related to PV business partner and supplier oversight activities including PVAs, etc., to ensure regulatory and past inspection commitments are considered.
• Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
• Contributes to any relevant quality and compliance governance in Takeda, including the PV Compliance Metrics Oversight Committee (CMOC) and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.
• Partners within PVMQ and R&D Quality and with other pharmacovigilance and medical functions to ensure alignment on both quality and business objectives.

What you bring to Takeda:

• 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 and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Advanced knowledge in strategic supplier quality oversight
• Experience must include successful development and implementation of a clinical or pharmacovigilance audit program
• Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
• Skilled in managing global, cross-functional projects.
• Excellent communication and interpersonal skills with the ability to communicate complex information.
• Proven abilities to promote shared responsibilities across teams
• Demonstrates ability to share knowledge and expertise with managers to support managers development
• Fluency in written and spoken English, additional language skills a plus.

What 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 reimbursement

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:

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold and/or wet environment.
• Must be able to work multiple shifts, including weekends.
• Non-Exempt Roles only: Must be able to work overtime as required.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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.

This posting excludes Colorado applicants.

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EEO Statement

Takeda 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.

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