Quality Manager

Established in 1996 and rebranded to Scout in 2024, we built our foundation on planning meetings for numerous organizations within the life sciences sector (Scout Meetings). In response to emerging industry needs, we expanded our services to include Scout Clinical, one of the top providers of clinical trial patient travel and reimbursements, and Scout Academy, our secure, online, on-demand learning management system that ensures global compliance.
 
Scout is recognized as a leader in our field for innovation in service, attention to detail, our stellar team members, and making the complex easier. If this interests you, we’d love to have you join our rapidly growing team!

Position Summary:
We are looking to hire a talented, eager, and skilled Quality Manager to join our team in a fully remote position. The Quality Manager will support the Quality group in the areas of document control, internal and external audits, corporate training, and change management. Specifically, they will be responsible for creating, maintaining, and releasing company documents, revision control, filing, storage, and retrieval. They will also be responsible for managing the interconnectivity of Internal Documents, External Standards, and gap analysis.
Responsibilities of this position include but are not limited to:

• Manage, control, maintain, complete, and/or retrieve Scout documentation including, but not limited to, Quality, Operations, SOC2 Compliance documents, IT policies, vendor-related documents, and finance-related documents. 

• Develop standardized templates and an organization-wide style guide to improve typography and content consistency. 

• Create and ensure compliance with templates, style guides and training materials, and collaborating with technical writers. 

• Create/revise, oversee the review of and maintain procedures, SOPs, Work Instructions, and obsolete documents. 

• Establish release documentation schedule providing product-approved external release notes and related knowledge base content. 

• Implement a cross-departmental Change Control Board (CCB), thus enabling a scheduled review cycle for documentation validity. 

• Manage Change Request Process (CRP) to capture internal and external feedback and requests. 

• Establish pre-publication content review and approval by Product Managers and client-facing support teams. 

• Oversee the Change Management policy and activities, scheduling quarterly CM meetings or emergency change advisory board meetings, ensuring all documentation is gathered according to the plan, and changes are closed once the checklist is completed. 

• Manage all staff training activities: ensure new hires receive regulatory and role-specific training during onboarding; ensure training is maintained and kept up-to-date. 

• Manage customer complaint process by documenting all complaints, incidents and escalations, communicating with appropriate personnel/groups, and resolving in a timely manner. 

• Perform internal audits. 

• Oversee vendor for annual internal company audit, manage audit report, and collaborate on audit remediation with Sr. Quality Manager. 

• Assist Sr. Quality Manager with client audits 

• Complete all required initial and ongoing training within a reasonable or provided timeframe.

• Collaborate with the RFI Manager and Academy group on the Knowledge Base to support and improve the efficient completion of RFIs and Client Questionnaires. 

The ideal candidate will have the following experience, skills, and knowledge:

• High School Diploma (required) 

• Bachelor’s Degree (required) 

• Minimum of 5 years’ experience within the Technical Writing/Document Control profession 

• Minimum 3 years' experience in a management role

• Experience working in a Regulated Industry (Medical Device, Pharma, Clinical Trials) environment preferred. 

• Experience with Electronic Document Management Systems (e.g. Jira, Agile Cloud, Master Control, M-Files) preferred. 

• Experience in planning for and participating in internal and external audits. 
   

The ideal candidate will have the following competencies and qualities:

• Excellent communication and organizational skills 

• Ability to use common software productivity tools, such as Word, Excel and PowerPoint 

Scout offers a competitive compensation and benefits package that includes contributions to your HSA and 401k. Visit our website at www.scoutclinical.com or follow us on LinkedIn for other employment opportunities.
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