Onsite and remote combination position
MUST have experience with technical and GMP training, strong project management experience, and working cross-functionally with quality, manufacturing, etc
Learning and Development (L&D) is a centralized team whose ultimate responsibility is to ensure all employees at Sanofi Specialty Care, in the Boston Hub, possess the required knowledge to successfully do their jobs. To fulfill this responsibility, the L&D Site Support and L&D Learning Services teams work as two interwoven teams ensuring proper evaluation of training needs, accurate assignment of training, qualified delivery of courseware, ongoing assessment of knowledge application, and maintenance of detailed records to illustrate individual qualification.
Learning and Development strives to foster a learning culture where effective training and continuous improvement results in a well-trained workforce with the right capabilities who will deliver products for patients exceeding Sanofi's high-quality standards.
The Principal Training Specialist, reporting to Learning and Development Site Support Management, supports the overall execution of the training process at Specialty Care sites with the main goal of ensuring those working in GMP areas, and those supporting these areas, are qualified to do their jobs. The Principal Training Specialist accomplishes this goal in two ways:
Collaborating with L&D peers at other sites to ensure the process is current, standardized, in a state of compliance, and aligned with industry best practices.
Engaging directly with Subject Matter Experts and department managers in the design, development, delivery, and monitoring of learning plans and programs.
The Principal Training Specialist works mostly with Trainees at the sites. This relationship begins the first week of any new employee's career at Sanofi with the delivery of New Hire Orientation by the Specialist. End User connections continue as the Specialist works with the Trainee and their Manager on the development of a personalized learning plan for the new hire. As the Trainee progresses through their career, they will interact with the Principal Training Specialist who delivers select, instructor lead training and facilitates training record management. As the new hire gains proficiency and becomes an expert in their area, the Principal Training Specialist will work with them and other subject matter experts and process owners to assess training impact of new or revised procedures, and when needed, will perform intake assessment for learning needs to feed the instructional design process.
In addition to these core job efforts, the Principal Specialist participates in projects, stemming from the L&D group or from other efforts throughout the business, to drive improved organizational and individual performance. The Principal Training Specialist will facilitates information flow between subject matter experts and vendors to assist with the development and deployment of training programs. When issues arise, the Principal Training Specialist will support/own/assist with investigations and corrective actions associated with failure points.
Success in this role depends on the ability of the Principal Training Specialist to demonstrate a solid understanding of educational theory, GMP training and associated regulations, use of typical GMP training tools, change management, and how these impact training from managers to the shop floor. The Principal Training Specialist must have excellent interpersonal and communication skills and embrace a collaborative, people first approach to ensuring trainees and their managers are successful.
Partner with and support Trainees and their Managers to ensure state of control and compliance readiness with regard to personnel qualification
Deliver New Hire Orientation, (v)Train the Trainer, and OJT Training and other core L&D programs
Help maintain personnel training files and delivers training.
Assess impact of changes to procedures and processes to associated training materials and coordinate revision or acquisition and/or development of content
Build and maintain working relationships with subject matter experts to create, review, and edit training materials, facilitating the timely accomplishment of learning related deliverables
Compile and present metrics and KPI's which reflect training System health
Support identification of training related Event root causes
Participate in Audit and Inspection of the Training System
Contribute to L&D and site level projects
Model our competency-based philosophy to learning plan development and proliferate alignment with the competency framework
Build partnerships with L&D team members, network sites, and out of network teams to evaluate, test, and recommend continuous improvement initiatives, such as the investment in content development tools, delivery methods, learning technology solutions, and the evolution of the overall training System
Continuously assess current state environments and their effectiveness, discuss future state needs, and support changes to ways-of-working to address gaps
It is expected that the individual performing this role effectively demonstrate the following competencies:
Technical and GMP Training: Established at training and training in a regulated environment
GDP (Good Documentation Practices): In-depth knowledge of GDP practices and can teach and develop others in GDP principles that comply with regulatory requirements
Change Management: Understands local change initiatives and participates in cross-functional change projects
Project Management: Aware of project management principles needed to achieve defined goals
Manage Learning Products: Supports the management of learning products from initiation to implementation
Coaching: Is aware and open to the value of coaching to reach full potential
Embraces Change: Adjusts to fast paced environments and takes accountability to deliver the best solutions
Cooperates Transversally: Collaborates effectively with peers, stakeholders, and partners across the organization locally
Team Leadership: Contributes to a team, understands personal role, goals, strategic alignment, and embraces team values
Inspiring: Is inspired to work with team members towards a common goal
Bachelor's degree with 5 years' of experience in Training and similar experience working in a regulated environment - OR - HS/GED with 9 plus years' experience
Five years' of experience developing and delivering training programs
Proficiency in Microsoft PowerPoint, Word, Excel.
Five years of experience with Learning Management Systems.
Experience performing work that requires decision making and the consistent exercise of independent judgment and discretion.
Experience in working towards objectives
Strong written and verbal communication skills.
Ability to work onsite, as needed, to support business needs
Manufacturing and/or Quality experience, preferably both
Knowledge of Articulate Storyline or other e-learning course development software
Willingness to be innovative and courageous to challenge the status quo
Apply level knowledge of learning management systems
Expert level ability to communicate with Trainees and their Managers
Special Working Conditions:
Occasional travel between facilities in the Boston area
Potential off hours and weekend support, as needed
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Principia Biopharma Inc.