Your new company

HAYS Life Sciences has a fantastic permanent opportunity with our client, a well established global biotechnology company who are seeking an experienced Site Quality Lead on a long-term basis to lead a team while being at the forefront of quality operations for their Mayo-based site.

The company possesses a significant headcount of over 150 facilities worldwide and a proven track record of involvement in bringing drugs through the clinical trials phases in recent years thanks to an expansive portfolio ranging from oncology to the rare disease space.

Your new role

• 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: audits of regulatory records and reports; inspections of facilities and equipment; investigations, audits of methods, practices, and controls; review/approval of SOPs; 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.

What you'll need to succeed

• BSc. in a relevant Science discipline.
• Significant track record of working to GMP standards within a Quality Assurance function is essential.
• Established track record string leadership and people management.
• Proven track record as a competent people leader, with experience of managing groups of more than 10 reports is ideal.
• Further experience of working within a Quality Control/Analytical function prior to moving into Quality Assurance is highly desirable.
• Previous experience acting as host of client and regulatory inspections quality is essential especially dealing with regulatory bodies such as HPRA & FDA.
• Meticulous attention to detail and high level of accuracy.
• Good working knowledge of pertinent regulations.
• Demonstrates strong leadership ability, communication, and facilitation skills.

What you'll get in return

• Comprehensive benefits package from day one, including a pension contribution, private medical for you and family members, private dental care, illness cover, bonus

• Global opportunities and strong career progression

• Flexible hybrid working model.

What you need to do now

If you're interested in this role and want to discuss further, click 'apply now' to forward an up-to-date copy of your CV, or call me now 0860675277.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.