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JOB SUMMARY

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Sr Training and Learning Specialist.

This position is responsible to ensure the compliance, systematic structure, and effectiveness of the SPL-wide training system, this role is responsible for establishing and continuously optimizing the company-level training management system. Coordinates the planning and implementation of both GxP and non-GxP training, and based on competency standards or requirements, design and develop corresponding training solutions and learning pathways. The role collaborates closely with Quality to ensure GxP training meets regulatory requirements and follow up on the execution of training across departments, responds to training needs from various business functions, and drives the effective implementation of training across the organization, supporting operational compliance and enhancing organizational effectiveness.

Responsibilities include:

• Establish and continuously optimize the company-level training framework: establish training pathways covering different scenarios, including onboarding, job-specific training, and retraining/requalification management; develop company-level training framework documents that clearly define roles, processes, and management standards.
• Capability development & training framework development: for critical roles and target employee groups, collaborate with different functions to design training curricula and training pathways based on business needs, role capability requirements, and identified capability gaps, and develop corresponding training programs to support employee capability enhancement and continuous organizational capability development.
• Training curriculum & Trainer resource development: establish a company-wide training curriculum structure (including course catalog and curriculum architecture); coordinate internal trainers and external training resources; and continuously build and enhance training curriculum assets and trainer resources through the ongoing delivery of training programs and topic-based training initiatives.
• Training system and training data management: utilize and maintain GxP and non-GxP training-related systems to ensure training records are complete, accurate, and traceable; coordinate and follow up on issues arising during training implementation, supporting the daily operation of the training system and effective management of training data.
• Drive consistent implementation and alignment of the training framework across functions: ensure consistent execution of training structures, rules, and standards across functions; support cross-functional alignment of the training framework; and provide feedback on training framework implementation consistency.
• Coordinate company-level GxP training planning (annual/periodic): develop a company-wide GxP training plan based on business needs, ensure training plans are reviewed and approved by Quality, covering key positions and core processes.
• Collaborate with Quality to ensure GxP training compliance: drive the review and approval of company-wide training content; ensure company-wide training execution and records comply with GxP requirements (e.g., SOP compliance and data integrity); and support regulatory inspections and audits.
• Monitor training and qualification status for critical roles and identify risks: monitor training completion and qualification/requalification status for critical roles; identify training gaps, qualification expiry, and capability-related risks.
• Coordinate company-wide non-GxP training planning: coordinate company-wide non-GxP training planning covering onboarding training, topic-based training (e.g., leadership, frontline management, communication and execution), and business/role-based training; develop annual non-GxP training plans based on organizational development and business needs, with the objective of supporting employee role readiness and organizational capability development.
• Support translating training needs into training project design: convert business needs into training programs or curriculum proposals, and collaborate with relevant stakeholders to drive training program design and delivery.
• Coordinate and drive the implementation of company-wide training programs: coordinate training resources and implementation plans to ensure timely execution; regularly deliver company-wide training execution and review reports (including training coverage and progress tracking).
• Follow up on training execution across functions and drive continuous improvement: ensure training is conducted as required, on time, and in compliance, with outcomes reflected in the annual training review report; track and follow up on issue resolution to closure.
• Establish and operate training effectiveness evaluation mechanism (including guidelines, toolkit, etc.), drive the shift from "completion status" to "training effectiveness", conduct periodic evaluations or reviews;
• Analyze training and capability issues based on quality data, identify capability risks combined with deviations/OOS/recurring issues, generate correlation analysis reports.
• Support key position capability gap identification and improvement, collaborate with departments to clarify capability requirements and gaps, provide gap analysis and recommendations.
• Provide day-to-day support to the HR team as needed.
• Work collaboratively with HR team on key initiatives.

Job Requirements and Qualifications:

Education: Bachelor's Degree or above required, preference for STEM or Management disciplines

Experience: 5 plus years training management, learning and development, or related areas required, experience in Manufacturing or regulated environments preferred

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.