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  • DUBLIN 2
  • Job reference number:15420785
  • Client ID:RI/JO-1901-422348_3
  • Posted on:11-JAN-2019
  • Location:GALWAY
  • Job type:PERMANENT

Quality Manager

My client in the west of Ireland is seeking a Quality/Regulatory Compliance Manager Reporting to the Senior Director, Global GMP QA, this role shall be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption.

Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled.
Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
Assist in the development and presentation of regulatory training for Quality Assurance and operations staff.
Schedule resources to manage compliance systems and assure timely completion of: (1) audits of regulatory records and reports; (2) inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and controls; (5) review/approval of SOPs; (6) approval of Change Controls.
Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
Meet with operations personnel to explain audit findings, resolve conflicts, and consult on corrective and preventative actions.
Interface with Regulatory Agencies during inspections.
Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
Represent the corporation during regulatory and client inspections/audits.
Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits.
Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
Track corrective actions and apprise management of their status.
Assure vendors and suppliers identified/designated are assessed for the compliance with applicable regulatory requirements.
Participate in Regulatory Affairs and Compliance projects and programs.
Perform general auditing duties for compliance with quality standards.
Prepare written reports on audit and inspection activities.
Review SOPs.
Communicate all identified compliance and quality risks to his/her supervisor.
Assist with Vendor Assessment, client audits and subcontractor audits.
Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
Manage activities of assigned group(s) to ensure optimum performance of the group/function.
Responsible for personnel management activities such as: scheduling, personnel actions,training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
Assist in the development and recommendation of departmental budget and authorize expenditures.
Develop and oversee the implementation of departmental training programs, including orientation.
Support the policy of equal employment opportunity through affirmative action in personnel actions.
Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
Perform duties in accordance with GLP, GMP or GCP according to the requirements of the assigned task.
Perform all other related duties as assigned

Candidate Overview:
BSc. in a relevant Science discipline.
5-10 years experience of working within a GLP/GMP environment with at least 5 of those in a Manager/Supervisor role.
Previous quality auditing experience essential especially dealing with regulatory bodies such as HPRA & FDA.
Meticulous attention to detail and high level of accuracy.
Proven track record of leading and motivating a team.
Good working knowledge of pertinent regulations.
Demonstrates strong leadership ability, communication, and facilitation skills.
Excellent interpersonal & communication skills both written and verbal.
Excellent IT Skills MS Word, Excel, PowerPoint.

This job originally appeared on RecruitIreland.com