Quality Assurance Manager

2 weeks ago

Gillingham, Kent, United Kingdom Henry Schein Full time

Job Description

  • To act as the EU Responsible Person to uphold the activities listed in the relevant regulatory requirements and ensure compliance with applicable laws and regulations.
  • To manage the Integrated Management System (IMS) and ensure that processes are efficient and effective, in compliance with applicable regulations and standards.
  • To strategically manage the internal audit/self-assessment program for our range of products and activities across the UK and Ireland, ensuring that audits are planned and performed by risk, in line with business needs.
  • To manage and maintain the IMS, ensuring that all processes and activities within its scope of activity are maintained and in compliance with the business strategic approach and regulatory requirements.
  • To manage IMS quality system compliance obligations, certification, product storage and transportation requirements for all groups of products and service relationships.
  • To manage the Risk Management process, ensuring that a program of risk assessment is conducted in line with business activities and risks identified.
  • To manage adverse events, recalls, field safety communications, and complaints relating to products and services, ensuring Q&R oversight of process and timeliness of actions needed.
  • To manage the CAPA process, ensuring CAPAs are documented and completed in a timely manner.
  • To establish, maintain and oversee a consistent QMS culture within Henry Schein.
  • To lead the Management Review Process, engaging the management team to uphold leadership responsibility and authority designated.
  • To manage routine business operational requirements, Q&R key contribution in to processes and business strategies.
  • To ensure that the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
  • To contribute to product compliance initiatives and associated audits and verification activities needed to stay abreast of compliance requirements.
  • To conduct and oversee quality/GDP/pharmacovigilance training and compliance communications.
  • To ensure that the interfaces between Regulatory and Quality and other departments are managed optimally.

Henry Schein is committed to the principle of equal opportunities in employment in all spheres of its operation.

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