Senior Quality Training Specialist

Ardelyx•Waltham, MA

4d•$119,000 - $145,000•Hybrid

About The Position

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.

Requirements

Bachelor's degree in life sciences, quality, education/training, instructional design, business, or related discipline with 8+ years of experience in Quality, Quality Systems, training, learning and development, or a related function, within the pharmaceutical or biotechnology industry.
Demonstrated experience developing and facilitating instructor-led and/or virtual training, with strong presentation, facilitation, and audience-engagement skills
Strong knowledge of adult-learning principles and experience developing effective training materials, presentations, job aids, and knowledge assessments
Strong working knowledge of GxP principles, Quality Management Systems, and regulatory expectations related to employee training, qualification, documentation, and data integrity
Experience administering or supporting an electronic Learning Management System (LMS), including curricula, assignments, training records, compliance monitoring, and reporting; experience with validated/GxP systems preferred
Strong written and verbal communication, interpersonal, organizational, and project management skills, with the ability to collaborate and influence effectively across functions and organizational levels
Demonstrated analytical and problem-solving skills, attention to detail, and a continuous-improvement mindset, with the ability to manage multiple priorities independently and exercise sound judgment in a dynamic environment

Nice To Haves

Experience supporting audits, regulatory inspections, investigations, or CAPAs is preferred

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 and implement continuous improvement opportunities for training processes and systems
Support training-related investigations and CAPAs, internal and external audits, regulatory inspections, and other QMS activities by providing records, documentation, metrics, and subject matter expertise
Maintain current knowledge of applicable GxP requirements, regulatory expectations, industry practices, and learning methodologies, and recommend and implement opportunities to improve the effectiveness and efficiency of the Quality Training program