Associate Director, Clinical Development and

7 giorni fa

Milano, Lombardia, Italia Alexion Pharmaceuticals,Inc. A tempo pieno

Associate Director, Clinical Development and Operations Quality

(Country Quality)

Location:
Milan, Italy

Reports To:
Director, Clinical Development and Operations Quality (CDOQ);

This is what you will do:

  • Under the direction of Director, Quality Lead for Clinical Development Country Operations, the Associate Director, Quality Operations Lead (AD, QOL) is accountable as Clinical Operations Management (COM) quality support and is responsible for driving a culture of data and risk driven quality oversight of the clinical trials. The AD, QOL is responsible for providing quality-focused leadership for execution of Rare Disease Business Unit at the country and site level.
  • The Associate Director, Quality Operations Lead (AD, QOL) is responsible for active engagement with Country Operations Team to support a culture of sustainable regulatory compliance at country and site level via the riskbased quality management principles within and across portfolio. The AD, QOL will be responsible for proactive process efficiencies' assessment and building remediation/optimization in partnership with business process owners and COM organization as applicable.
  • The AD, Country level QOL will act as clinical compliance advisor/partner to the COM team. This role will work closely with COM Team and and Study QOLs to proactively identify country level Key Quality Indicators (KQIs) and develops mechanisms of KQI oversight and trending.
  • This role will collaborate closely with Study Quality QOLs and risk/issue owners to assure systemic and systematic risks and issues are communicated in a timely manner to be managed through action and resolution.

You will be responsible for:

  • In alignment with Director Clinical Development and Operations Quality, the AD, Country QOL supports development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio across all Therapeutic Area(s) (TAs) at country level.
  • Provide Quality advice to Clinical Operations Management (COM) group globally related to GCP compliance of COM processes and their continuous improvements.
  • The CQOL is responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.
  • Provide advice to Local Study Teams on procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
  • Support local management in the planning and conduct of local quality control activities including but not limited to performing accompanied site visits. Performs any required QC visits / QC activities with local staff and maintains the annual quality plan updated.
  • Work closely with COM team and other quality partners to proactively identify country level Key Quality Indicators (KQIs). Develops mechanisms of KQI oversight and trending. Provide local COM with information regarding status of quality issues and quality trends observed in COM.
  • Collaborate with other quality representatives and supports local study teams to resolve quality and compliance issues.
  • Review regularly Protocol Deviations and ensures Quality Issues are reported within the appropriate timelines to local Authorities and in internal review systems according to QI process.
  • Support the local organisation in the preparation for, conduct of and responses to audits and regulatory inspections.
  • Give regular feedback and Lessons Learned on audit and inspection findings to relevant COM and regional/ global CQ network.
  • Identify and ensure resolution of potential risks based on previous study/systems QC results, audit and inspection results and current routine quality management work.
  • Identify and organise/provide ongoing and ad hoc training of local staff according to local training needs, in cooperation with local COM leadership:
  • introductory training to new staff, including Procedural Training,
- ad hoc local training solutions e.g., as result of serious or recurring quality issues.

You will need to have:

  • Bachelor's degree in life science, or equivalent field, required.
  • Minimum of 810 years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.
  • Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)
  • Significant experience with GxP investigations, risk assessments and CAPA management.
  • Experience participating in regulatory inspections.
  • Functional planning experience and ability to develop functional vision, priorities and tactics.
  • Experience with multinational products and regulations as well as with mandated risk management plans.
  • Experience in managing, mentoring and

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