Quality Systems Manager

HERO

Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Quality Systems Manager

Apply Now

Job ID: JOB-12042
Quality Systems Manager

Our client a leading pharmaceutical company is recruiting for an ambitious Quality Systems Manager to join the team in Sligo. You will be responsible for leading a high performing team, coordinating the development and maintenance of the quality system, ensuring all products manufactured meet the requirements of patients, company and regulatory authorities.

Key responsibilities:

  • Lead and develop the Quality System function and team to deliver a best in practice Quality System driving performance and compliance.
  • Take responsibility for compliance with Quality System including, Management Review Coordinator, Management Representative and NTM coordinator, Supplier Program, CAPA, Change Control, Training, Product Quality Review, Inspection Readiness & Management, Internal Audit, Complaints, Quality & Technical Agreements, as well as Continuous Improvement and Simplification Initiatives.
  • Prepare and maintain Site Master File, Quality Manual and Quality Plans.
  • Ensure that products manufactured at AbbVie meet the requirements of end-users, Regulatory Authorities and the company.
  • Develop and maintain performance measurements of the quality system and report on this at management review meetings and during quality performance meetings.
  • Liaise with AbbVie Quality and Compliance Group, FDA, HPRA and other Regulatory bodies to ensure Quality Systems compliance by all departments and personnel.
  • Manage ongoing Quality Systems Compliance issues, and present technical data to stakeholders to ensure prompt decisions on related issues.
  • Act as Designee for Biologics QA Site Lead as required.

Key requirements

  • You wil have a 3rd Level Qualification in Science, Quality or Engineering to Degree Level (Masters Preferable) with 8 + Years experience in the healthcare/pharmaceutical/biopharmaceutical industry
  • Minimum of 3 Years People Management experience
  • Demonstrated audit/inspection management experience
  • In-depth knowledge of GMP Requirements and Regulations.
  • Ability to make Quality decisions and run the business while keeping patient-focused and safeguarding the company’s reputation.
  • High level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures.
  • Results-driven striving to meet all targets and metric standards as set by department/site and division leader.
  • Strong communication skills, both verbal and written, are required for the execution of this role.

For more information on this role in Sligo please contact Mark Wilson on 086 0449473  talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

Mark Wilson

JOB-12042

Apply Now

Quality Systems Manager

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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