This role is a key role in CSO organization to ensure day-to-day compliance within the organization as it pertains to GxP documentation, training, and other compliance activities performed in the team. The Compliance Manager will work with multiple departments across Product Development to communicate effectively on all compliance related issues.
Role & Responsibilities:
Training and Documentation Content management and daily support:
- Handle daily training and documentation tasks, queries independently ensuring compliance with GxP documentation and data integrity principles. escalate technical and/or business issues promptly and follow through until resolved.
- Develop training curricula, evaluate/monitor training materials, record training activities and program effectiveness.
- Conduct training impact assessments, organize, and create training procedure guides and/or course materials and provide training to functional teams.
- Generate Metrics for Training, Documentation and other compliance related tasks. Ensure Training and Documentation data are properly captured, stored, archived, available and maintained as per Data Integrity principles outlined in site procedures.
- Supervise/Manage contingent workers/junior staff members on day-to-day Documentation/training related task assignments as applicable.
- Create, review, and maintain CSO controlled documents (SOP, Forms, TIA, OJT, etc) as a Content manager of various PD Electronic Document Management systems (ie PDHQ, BMS Docs-Veeva, Docman, etc).
- Support activities related to periodic reviews, CAPAs, and maintenance of CSO-controlled GxP documents (CVs, JDs, signature logs, forms, DIRAs, Risk Assessments).
- Support all data integrity related work as assigned
- Ensure compliance related GMP documents are issued in a timely manner. Support self-inspections/audit related tasks during audit.
- Participate in cross training if required DOC-718897, Version 2.0 Page 2 of 2 The Official Copy is the electronic file. Verify document is the current version before proceeding.
- Act as a decision maker while balancing speed, quality and risk.
Digital Solutions and SharePoint Management:
- Evaluate and recommend electronic solutions to streamline current workflows.
- Establish and manage a SharePoint site to enhance team communication and collaboration.
- Identify and implement digital solutions to replace paper-based processes or enhance existing processes.
Quality and Compliance:
- Perform quality investigations, including root cause analysis, actions/proactive initiatives and ensure timely completion of investigations.
- Ensure compliance with GxP documentation and data integrity principles in daily work.
Continuous Improvement:
- Propose and support digital solutions to improve process efficiency.
- Create end-to-end workflows and job aids for assigned processes.
Experience & Qualifications:
- BA/BS degree with 5+ years’ experience with Training Management (i.e SuccessFactors, Compliance wire, etc) and QMS Documentation Systems (i.e., CDMS, EDMS, Veeva etc) or MS degree with 3+ years of experience
- Advanced Knowledge of Microsoft Office (Word, Excel, SharePoint etc)
- Experience in Deviation/Investigation writing, Change Controls, etc Excellent attention to details with ability to work accurately and independently in a busy demanding environment.
- Strong collaboration and communication skills. Ability to successfully work within strict timelines showcasing excellent organizational and time management skills. Ability to negotiate and act as a mediator between functional areas while meeting timeline and pay attention to details.
- Experience using AI tools for process improvement is considered an asset.
The starting compensation for this job is a range from $96,940 – $117,500, plus incentive cash and stock opportunities (based on eligibility).
