Global Quality Director

11 hours ago

Gillingham, Kent, United Kingdom Henry Schein Full time
Job Description

We are seeking a highly skilled and experienced Global Quality Director - EU Compliance Specialist to join our team at Henry Schein. This is a key role that will play a crucial part in ensuring compliance with all regulatory requirements.

About the Role
  • The successful candidate will be responsible for managing the Integrated Management System (IMS), ensuring that processes are efficient and effective, and are in compliance with applicable regulations and standards.
  • You will have responsibility for ensuring that audits are planned and performed by risk, in line with business needs, and auditors' competencies are current and in place.
  • This role involves managing IMS quality system compliance obligations, certification, product storage and transportation requirements for all groups of product and service relationships.
  • You will also manage critical suppliers and outsourced service provision through maintenance of agreements, procedures, and routine assessments.
Key Responsibilities
  • To act as the EU Responsible Person to uphold the activities listed in the Dublin Ireland WDA license and related business activities.
  • To fulfill the responsibilities of the EU GDP RP by ensuring the HPRA guidelines on Good Distribution practice are trained out and complied with.
  • Management of any critical suppliers and or outsourced service provision through maintenance of agreements, procedures, and routine assessments.
  • 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 the adverse events, recalls, field safety communications, and complaints relating to product and services.
  • To manage the CAPA process ensuring CAPAs are documented and completed in a timely manner.
Requirements
  • A strong background in quality assurance and regulatory affairs, with experience in managing Integrated Management Systems.
  • Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders.
  • Strong analytical and problem-solving skills, with the ability to identify and mitigate risks.
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines.
What We Offer

We offer a competitive salary of £80,000 per annum, plus a range of benefits including pension scheme, life insurance, and annual leave.

HENRY SCHEIN UK HOLDINGS strives to operate a policy of equal opportunity and not discriminate against any person gender, race, colour, nationality, ethnic or national origin, religion, sexual orientation, marital status, disability, age or any other characteristic protected by law.

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