Quality Business Systems Manager

• Leads the implementation and maintenance of PLM and Quality and Regulatory Management systems including the configuration, integration, data migration, administration, and technical problem resolution​

• Develop and execute test protocols as part of systems verification and/or validation according to internal standards and 21 CFR Part 11 requirements​

• Ensure systems maintain compliance with internal/ external requirements through data-driven oversight ​

• Be the primary liaison between internal and external cross functional groups including product development, quality, regulatory, local & global IT and software providers to implement and/or optimize tools and processes​

• Partner with Ops / ERP system management team to ensure lot traceability capability​

• Analyze underlying system issues and identify/define alternatives, assess feasibility and manage implementation of recommended solution​

• Establish key metrics and develop reports to allow metrics tracking and analysis​

• Leads OLLY site-wide training for new users and improvement releases​

• Develop SOPs and Job Aids in support of systems implementation, operation and training​

• Provides user support to troubleshoot problems / resolve technical issues​

• Recommends new approaches where appropriate to improve processes/workflows to facilitate the organization achieving our business objectives ​

• 7 - 9 years System/IT/Configuration and administrative support experience in an FDA regulatory industry preferably in a Quality and Operations function ​

• Bachelor’s Degree in related field, Computer Engineering preferred​

• Experience implementing, enhancing and integrating larger business management systems such as PLM, ERP and Quality solutions in compliance with 21 CFR Part 11​

• Proven track record delivering compliant technology through the full software development lifecycle including process documentation, specification development, design, programming, testing, and implementation​

• Strong organizational and communication skills with the ability to clearly explain and visualize processes and workflows.​

• Ability to elicit business requirements and translate into industry standard documentation​

• Ability to see the “big picture” to connect data and processes across systems to drive efficiencies and ensure compliance​

• Travel 10% - 15% or as needed​

• Initial video screen with a member of our Talent team
• Round 1: Conversation with the Hiring Manager + 1-2 conversations with other Ollies on the team
• Round 2: 2-3 conversations with team or cross functional Ollies
• Final Round: Homework*

*At OLLY, our final round is called Homework. Candidates who participate in this round are given 3 questions in advance to answer and present to the interview panel they previously spoke with in the process. We understand every candidate is different. If you need a reasonable accommodation to adjust this procedure, please let us know as possible so that we can evaluate and provide other options that work for your needs

THE DETAILS​

LOCATION: Remote- USA​

HOURS: full time, exempt (salary)​

MANAGER: Quality Management System Director​

PLEASE NOTE: Candidates must be authorized to work in the United States without sponsorship.

The pay range for this position is $109,000 - $135,000 dependent on experience. This position is bonus eligible and Long-Term Incentive eligible.​

WHAT WE OFFER: 

• An opportunity to work with an intelligent, inspiring, and extraordinarily fun team 
• 100% employer-paid medical coverage for employee only, dental + ortho, and vision insurance 
• 4 weeks PTO + paid holidays + 12 Mental Health Days per year
• 100% Paid parental leave, Fertility + Adoption Benefits 
• Annual Bonus + Long Term Incentive Plan  
• 401(k) plan with Employer Match 
• Hybrid Work + Wellness + Cell Phone Stipends 
• Free product 
• And much more!