Pharmacovigilance and Medical Quality Compliance Lead


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Job Description

About the role:

  • Provides quality oversight and direction to business partner audits of Takeda and supports inspections, promoting operational and compliance excellence, quality risk management and knowledge management
  • Partners with the different functions across the globe that impact the PV system in identifying quality and compliance risks, pertaining to quality events/deviations and business partner audits; conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Takeda’s values and strategic priorities.
  • Reports to the Head of PVMQ Compliance and contributes to development and implementation of PVMQ Compliance strategy and vision.

How you will contribute:

  • Support all inspections under PVMQ’s remit, including quality review of storyboards, documents/information requests and objective CAPA supporting evidence. 
  • Leads the PV Business Partner (BP) PV audits readiness activities involving  engagement with relevant functions and stakeholders including, but not limited to, Global Patient Safety Evaluation Compliance, Global Regulatory Affairs Compliance, Medical Information, Product Complaints and Quality Compliance Systems. 
  • Hosts PV business partner audits and provides direction to relevant functions and Subject Matter Experts (SME).
  • Communicates the progress of business partner audits daily, summarizing succinctly the business partner audit activities and potential observations and mitigation activities. Effectively and timely escalates to management.
  • Leads and manages the business partner audit response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed.
  • Oversees the completion and closure of the business partner audit CAPAs. Mitigates and escalates any risks to the timely completion of CAPAs. Ensures effectiveness checks are developed, if appropriate. Provides input to the effectiveness check plans and reviews and approves outcome.
  • Supports Quality Compliance Systems internal PV audits as the PVMQ Compliance subject matter expert in the quality review of audit responses.
  • Acts as Subject Matter Expert (SME) on the PVMQ Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent PVMQ Compliance in these topics in business partner audits.
  • Leads complex quality investigations under PVMQ remit. Provide Quality Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
  • 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.
  • Contribute to the development of lessons learned from on regulatory inspections, business partner audits and quality investigations. Deliver these lessons learned presentations independently.
  • Contributes to the development and monitoring of relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, contributing t its mitigation.
  • Contribute to cross-functional continual improvements projects that enable a compliant quality systems in the pharmacovigilance and medical systems.
  • Contributes to any relevant PV and Medical Quality and compliance governance in Takeda, including the PV Compliance Metrics Oversight Committee (CMOC), communicating any quality or compliance risks and opportunities, continual improvements and successes.
  • Review controlled procedures related to pharmacovigilance to ensure regulatory and past inspection commitments are considered.
  • Provide input in the pharmacovigilance agreement (PVAs) templates - sharing of inspection and audit findings, etc. Escalates any QA-relevant PVA issues/challenged.
  • Coach junior Compliance staff to support capability building and talent development.
  • Leads PSMF compilation of data to ensure timely and accurate update of quarterly PSMF publications.
  • Oversee the change control lifecycle activities impacting the PV system in alignment with Global Quality internal policy and procedures  

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.
  • 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 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

Important 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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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Locations

AUT - Wien - Technologiestraße 5

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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