Hologic Sr. Solution Analyst, Quality Systems in Marlborough, Massachusetts
Primary job function includes the following:
Essential Duties & Responsibilities:
Function as the key IS point person for the Quality and Regulatory Areas by working with the Corporate and Divisional Quality and Regulatory teams to develop application strategies and roadmaps. Provide business process guidance, solution architecture and on-going operational support worldwide.
Partner with Quality and Regulatory leadership to establish priorities and develop business cases focused on projects that add business value.
Manage and communicate the IS PMO Portfolio for Quality and Regulatory.
To be a subject matter expert (SME) in the Agile and Oracle EBS Solution footprint for the Quality and Regulatory business areas.
Documenting “As Is” and “To Be” business flows including roles, responsibilities, master data management and governance.
Develop and maintain Solutions Portfolio for Quality and Regulatory.
Challenge legacy processes and policies that complicate the Quality and Regulatory Business Experience.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
Experience in Enterprise Technologies for Enterprise Quality management and Enterprise Product Life Cycle Management such as Oracle Agile PLM/eQMS
Solid understanding of core PLM, Quality, and Regulatory functions.
Skill and knowledge must span multiple business functions and related system solutions.
Ability to build strong relationships with stakeholders across all Hologic lines of business (and geographies).
Excellent presentation skills with the ability to facilitate meetings and document processes.
Ability to gather and evaluate business requirements, develop detailed functional specifications for potential business process improvements.
Collaborate with both business partners and technical partners (internal IS and external partners) to determine business need solution approach.
Create and deploy standardized solutions across the entire supply chain, optimize internal processes, and provide strategic value for Hologic.
Demonstrated ability to manage a portfolio of assigned deliverables with expected results per delivery/project plans.
Excellent interpersonal, adaptive communication and collaboration skills.
Experience with complex problem resolution and very strong analytical skills.
Ability to work independently and within a team environment.
Travel and work at any Hologic location globally as required.
- Bachelor’s Degree in Management Information Systems, Engineering or Business Management, or related fields preferred.
5+ years managing and supporting Quality and Regulatory Systems
Experience implementing and/or supporting Agile (PLM and Quality) or equivalent QA/RA Enterprise Solutions
Medical Device and/or regulated industry experience preferred.
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