Manager, Quality Assurance | Taiwan
Syneos Health
Taiwan
11天前

Description

WhySyneos Health? Join a game-changingcompany that is reinventing the way therapies are developed and commercialized.Created through the merger of two industry leading companies, INC Research andinVentiv Health, we bring together more than 22,000 clinical and commercialminds to create a better, smarter, faster way to get biopharmaceuticaltherapies into the hands of patients who need them most.

Evolve in a globalcompany that is always looking for ways to work smarter and more efficiently asthe only fully integrated Biopharmaceutical Accelerator.

You'll be supportedwith comprehensive resources based on today's emerging technologies, data,science and knowledge - instead of practices from the past.

Teaming with someof the most talented professionals in the industry, you'll gain exposure andwork in a dynamic environment to over-

deliver and outperform. A career withSyneos Health means your everyday work improves patients’ lives around theworld.

  • Regulations & Processes :
  • Local expert for ICH GCP and local regulations (incl. impact assessment of new / updated local regulations on local processes).
  • In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global / local processes to ensure a proper implementation of global / local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
  • Local expert for any quality related local processes.
  • Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and / or headquarters (if necessary).
  • Leads continuous improvements activities at the country level and supports or co leads continuous improvements activities at the global / regional level.
  • Training :
  • Local training point of contact and the liaison between local country operations.
  • In close cooperation with local country operations management, identifies local training needs and initiates local training activities.
  • Supports onboarding of local country operations personnel (quality related topics).
  • Quality Control (QC) Activities :
  • In conjunction with the local country operations management, coordinates and oversees all QC activities (local quality plan) by ensuring a proper execution of the Inhouse Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs).
  • In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs). .
  • On a regular basis and in collaboration with local country operations, looks into local trends, performs root cause analysis (if necessary), develops local action plan (incl.
  • sharing of results and training of local country operations, if required).

  • Audits & Inspections :
  • Primary point of contact for MRL Quality Assurance and Regulatory Agencies.
  • Manages and supports activities during the preparation / ongoing / follow up phase of an audit or inspection.
  • In cooperation with local country operations and / or headquarters, performs root cause analysis for audit observations / inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates / facilitates the responses to audit / inspection reports.
  • On a regular basis and in collaboration with local country operations, looks into local trends, performs root cause analysis (if necessary) and develops local action plan (incl.
  • sharing of results and training of local country operations, if required).

  • QualityCompliance Issue Escalation :
  • Communicates / escalates quality / compliance issues (incl. any potential trends) to local country operations management and RCQM.
  • If indicated, escalates quality / compliance issues to MRL Quality Assurance and / or MRL Compliance.
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary.
  • MRL Compliance Steward (if applicable).
  • Clinical Supplies GCP Investigations
  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).
  • Vendor Qualification :
  • Leads local vendor qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors.
  • Supports the Quality Management System (QMS) assessment for global and local
  • vendor qualifications.
  • Qualifications

  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Ideally, experience in managing audits and inspections.
  • Ideally, experience in coordinating and delivering training sessions.
  • Skills :
  • Superior oral and written communication and people management skills in an international environment.
  • Excellent project management and organizational skills.
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
  • Ability to analyze, interpret, and solve complex problems.
  • Ability to think strategically, objectively and with creativity and innovation.
  • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this job description are notexhaustive. The Company, at its sole discretion and with no prior notice, mayassign other tasks, duties, and job responsibilities.

    Equivalent experience,skills, and / or education will also be considered so qualifications ofincumbents may differ from those listed in the Job Description.

    The Company, atits sole discretion, will determine what constitutes as equivalent to thequalifications described above. Further, nothing contained herein should beconstrued to create an employment contract.

    Occasionally, requiredskills / experiences for jobs are expressed in brief terms. Any languagecontained herein is intended to fully comply with all obligations imposed bythe legislation of each country in which it operates, including theimplementation of the EU Equality Directive, in relation to the recruitment andemployment of its employees.

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