Manager Compliance Programs Learning and Development

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

The role of the Manager, Learning and Development provides high-level expertise in adult learning and acts as a lead in the education, training, and development discipline within the Quality department. This role provides support to ensure services, processes, facilities, reporting, investigations, audits, and/or systems are compliant to applicable standards and regulations. Reporting to the Director of Quality Management Systems, this role will support the implementation of the quality policy, the corporate learning and development strategy, the systems utilized for learning, development and training, and efficiency tools. The role will be an advocate for cross-functional collaboration, continuous improvement, process standardization, compliance, with the goal of driving continuous quality system, product, process performance improvements. This role may act as the delegate for higher level Quality functions as described and assigned under job responsibilities. The manager is responsible for supervising assigned direct reports, performing personnel performance evaluations, and is involved in hiring and termination decisions within the Quality organization.

Compensation
The target salary for this position is $92,340.00 annually.

The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.

Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Assists Quality leadership in executing the Quality Plan and ensuring compliance with applicable regulations and standards.
• Identifies, develops, and executes quality improvements. Integrates continuous improvement practices adopted by Versiti into quality systems, compliance, regulatory affairs and/or education and improvement activities.
• Provides direction, coaching, and mentoring to team personnel to achieve organizational goals.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Supports internal/external assessments as assigned and facilitates optimal communication between the department and the investigator/inspector/assessor.
• Reviews charts, tables, etc. to analyze metrics (quality and business). Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions.
• Reviews and approves standard operating procedures, validation plans and results, corrective action plans associated with audits and events, and other required documents for compliance as required.This includes reviewing regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management.
• Analyzes, reviews, approves, and monitors events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions.
• Strengthens Versiti's learning culture, ensuring trainers across the organization work consistently and collaboratively with Corporate Services and Service Lines to ensure learners have access to the knowledge and information needed to achieve department/organization goals
• Oversees the development and execution of the Versiti's learning strategy by implementing and managing the electronic Learning Management System
• Executes the development, design, implementation, analysis and evaluation of learning initiatives in support of Versiti's Quality and Compliance goals and ensures programs are compliant with applicable regulations and standards.
• Collaborates with and supports Corporate Service and Service Line departments on process, functional, and technical learning and development capabilities which are focused on meeting their unique department training needs and goals
• Develops, deploys, manages, and maintains learning solutions relating to leadership and quality culture throughout the organization
• Collaborates with department leaders to develop shared understanding of the learning and performance needs. Continually monitors best practices and learner assessments and adjusts techniques or recommends changes when appropriate
• Ensures that processes, programs, and practices align with Versiti core values; knowledge is curated and accessible to all employees; trainers collaborate and can leverage learning resources effectively and efficiently
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Education

• Bachelor's Degree (BA or BS) required
• Master's Degree (MA, MBA, MS, etc.) preferred
• Advanced degree in learning, development, education, adult learning, etc. is preferred preferred

Experience

• 7-9 years required
• 4-6 years of experience with a master's degree required
• 1-3 years in a leadership position, preferred
• Project/Program Leadership experience, required
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred

Knowledge, Skills and Abilities

• Knowledge of using professional concepts and company's policies and procedures to solve a variety of problems works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors required
• Ability to collaborate and influence cross-functionally (across service lines) to lead the development of new policies/ideas in Learning, development and training disciplines required
• Strong communication and business acumen skills required
• Requires a hands-on approach that requires strong leadership and people skills required
• Directs the application of existing learning and development principles and guides development of new policies, processes, and systems (including electronic) and ideas across a discipline/departmental area required
• Experienced professional with 8+ years of business experience (education in lieu of 3-4 years' experience may be acceptable) required
• Knowledge and experience with development and management of Electronic Document Management Systems and/or Learning Management Systems required
• Expert knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred

Licenses and Certifications

• Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE) preferred

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required
• Adult learning and development tools required
• Learning Management Systems (LMS) required

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