Senior Quality Training Specialist
Ardelyx
Pay: USD 119,000 – 145,000 a year
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Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
Position Summary:
The Senior Quality Training Specialist is responsible for the development, administration, delivery, and continuous improvement of the Quality Training program within the Quality Management System (QMS). This role independently develops and facilitates training for employees across the organization and partners with Quality, functional subject matter experts, and business stakeholders to ensure employees have the knowledge and skills necessary to perform their responsibilities in accordance with applicable procedures, regulatory requirements, and Company standards.
The Senior Specialist serves as a key subject matter resource for Quality training processes with responsibility for training delivery, curriculum management, compliance monitoring, training effectiveness, and continuous improvement. This role requires a strong facilitator who can translate complex Quality and compliance concepts into clear, engaging, and practical learning experiences.
This position is hybrid-based requiring 2-3 days onsite in our Waltham, MA Headquarters.
Responsibilities: Develop, coordinate, and facilitate instructor-led, virtual, and other Quality training programs, including onboarding, recurring QMS training, and training associated with new or revised processes, procedures, and systems
Partner with subject matter experts to develop effective training content and learning materials and provide guidance and coaching to internal trainers to support consistent and engaging training delivery
Apply adult-learning principles and appropriate instructional techniques to create effective learning experiences and evaluate training effectiveness through assessments, feedback, observations, and performance metrics
Partner cross-functionally to identify training needs, maintain appropriate curricula, monitor training compliance, and ensure personnel training and qualification requirements are effectively implemented
Develop and maintain Quality Training procedures, work instructions, job aids, training materials, and other supporting documentation in accordance with QMS requirements
Identify and implement process improvements for Quality Training and GxP documentation systems in accordance with QMS requirements
Generate and analyze training metrics and trends to identify compliance risks, evaluate program effectiveness, and recommend…