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It applications manager - quality systems

Limerick
Regeneron Ireland
Application manager
Posted: 3h ago
Offer description

This position manages a team responsible for the day-to-day maintenance, support, and development of Regeneron's IOPS IT Applications portfolio, including but not limited to EDMS, EQMS, EVMS, electronic forms, learning platform, and other supporting applications.
The role is responsible for the Raheen site while working closely with global counterparts on globally deployed systems.
It involves managing the application portfolio and associated support staff, driving audit readiness and compliance, and ensuring systems are maintained in a validated and compliant state.
Responsibilities
Manage a team of FTEs responsible for supporting and maintaining IOPS IT Applications, including performance management, mentoring, coaching, and staff development.
Work with staff on the development of annual goals; perform monthly performance reviews and develop annual performance evaluations.
Serve as the primary IT Applications manager for the Raheen site while collaborating with global counterparts to support and maintain globally deployed systems consistently and compliantly.
Collaborate with peer managers overseeing different application portfolios to ensure alignment, shared best practices, and coordinated delivery across the broader IOPS IT Applications function.
Drive audit readiness across the application portfolio; serve as the key point of contact during regulatory inspections and internal audits, ensuring systems and documentation are inspection-ready at all times.
Ensure all supported applications are maintained in a compliant and validated state; proactively identify and resolve compliance issues in accordance with regulatory requirements, IOPS SOPs, and corporate policies.
Work with the Validation Department to ensure applications are implemented and maintained in accordance with SDLC methodology and relevant regulatory requirements.
Maintain responsibility for the accuracy of system documentation, including User Requirement Specifications, Detail Design Specifications, Configuration Specifications, Test Plans, and Summary Reports.
Provide high-quality support to end-users, including user management, troubleshooting, training, and management of change requests.
Manage relationships with SaaS vendors and external service providers; oversee vendor performance, contract adherence, and ensure delivery of services in line with business and compliance requirements.
Develop and implement operational rigor and discipline using metrics and other operational controls; drive continuous improvement initiatives that enhance team performance and efficiency.
Contribute to and support the strategic vision and direction of the IOPS IT Applications function in collaboration with key stakeholders.
Ensure staff compliance with regulatory, corporate, and IOPS policies and procedures.
Qualifications
Enjoy collaborating with a team as well as working independently to develop solutions to complex problems.
Enjoy driving a creative mindset and collaborating to design, implement, and modify code or configuration or discover ways to simplify business processes.
Exhibit ingenuity, creativity, and resourcefulness in an evolving and sometimes ambiguous environment.
Have strong analytical and organizational skills, as well as excellent written and verbal communication skills.
In order to be considered for this position, you must hold a BS/BA in Information Technology or a related field along with the following experience levels:
Associate Manager: 6+ years of relevant experience, plus 1+ year of managing systems and teams.
Manager: 7+ years of relevant experience, plus 2+ years of managing systems and teams.
Senior Manager: 8+ years of relevant experience, plus 3+ years of managing systems and teams.
Equivalent combinations of education and experience may be considered.
Benefits
Health and wellness programs: medical, dental, vision, life, and disability insurance.
Fitness centers.
401(k) company match.
Family support benefits.
Equity awards.
Annual bonuses.
Paid time off.
Paid leaves, such as military and parental leave.
Equal Opportunity Employer
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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