Senior Quality Training Specialist
Ardelyx, Inc.
August 19, 2026
Remote friendly (Waltham, MA)
United States
Operations
Position Summary
Senior Quality Training Specialist responsible for the development, administration, delivery, and continuous improvement of the Quality Training program within the Quality Management System (QMS). Develop and facilitate training across the organization in accordance with applicable procedures, regulatory requirements, and Company standards.
Responsibilities
- Develop, coordinate, and facilitate instructor-led, virtual, and other Quality training programs (onboarding, recurring QMS training, and training tied to new/revised processes, procedures, and systems)
- Partner with subject matter experts to create training content; coach internal trainers for consistent delivery
- Apply adult-learning principles; create engaging learning experiences and evaluate effectiveness via assessments, feedback, observations, and performance metrics
- Identify training needs cross-functionally; maintain curricula; monitor training compliance; ensure qualification requirements are implemented
- Develop and maintain Quality Training procedures, work instructions, job aids, training materials, and supporting documentation per QMS requirements
- Identify and implement process improvements for Quality Training and GxP documentation systems
- Generate/analyze training metrics to identify compliance risks, evaluate effectiveness, and recommend continuous improvement
- Support training-related investigations and CAPAs, audits, regulatory inspections, and other QMS activities with records, documentation, metrics, and SME expertise
- Maintain knowledge of GxP, regulatory expectations, industry practices, and learning methodologies; recommend improvements to program effectiveness/efficiency
Qualifications
- Bachelor’s degree in life sciences, quality, education/training, instructional design, business, or related field with 8+ years’ experience in pharmaceutical/biotech Quality/Quality Systems/training/L&D
- Experience developing and facilitating instructor-led and/or virtual training; strong presentation/facilitation and audience engagement
- Strong adult-learning knowledge; experience creating training materials and assessments
- Working knowledge of GxP, QMS, and regulatory expectations for training/qualification/documentation/data integrity
- Experience supporting an electronic LMS (curricula, assignments, training records, compliance monitoring, reporting); validated/GxP systems preferred
- Strong communication, interpersonal, organizational, and project management skills; ability to collaborate and influence across functions
- Analytical/problem-solving skills, attention to detail, continuous-improvement mindset; ability to manage multiple priorities independently
- Audit/regulatory inspection/investigation/CAPA support experience preferred
Benefits
- 401(k) with employer match; 12 weeks paid parental leave; up to 12 weeks living organ/bone marrow leave; equity incentive plans; health plans; life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays
Senior Quality Training Specialist responsible for the development, administration, delivery, and continuous improvement of the Quality Training program within the Quality Management System (QMS). Develop and facilitate training across the organization in accordance with applicable procedures, regulatory requirements, and Company standards.
Responsibilities
- Develop, coordinate, and facilitate instructor-led, virtual, and other Quality training programs (onboarding, recurring QMS training, and training tied to new/revised processes, procedures, and systems)
- Partner with subject matter experts to create training content; coach internal trainers for consistent delivery
- Apply adult-learning principles; create engaging learning experiences and evaluate effectiveness via assessments, feedback, observations, and performance metrics
- Identify training needs cross-functionally; maintain curricula; monitor training compliance; ensure qualification requirements are implemented
- Develop and maintain Quality Training procedures, work instructions, job aids, training materials, and supporting documentation per QMS requirements
- Identify and implement process improvements for Quality Training and GxP documentation systems
- Generate/analyze training metrics to identify compliance risks, evaluate effectiveness, and recommend continuous improvement
- Support training-related investigations and CAPAs, audits, regulatory inspections, and other QMS activities with records, documentation, metrics, and SME expertise
- Maintain knowledge of GxP, regulatory expectations, industry practices, and learning methodologies; recommend improvements to program effectiveness/efficiency
Qualifications
- Bachelor’s degree in life sciences, quality, education/training, instructional design, business, or related field with 8+ years’ experience in pharmaceutical/biotech Quality/Quality Systems/training/L&D
- Experience developing and facilitating instructor-led and/or virtual training; strong presentation/facilitation and audience engagement
- Strong adult-learning knowledge; experience creating training materials and assessments
- Working knowledge of GxP, QMS, and regulatory expectations for training/qualification/documentation/data integrity
- Experience supporting an electronic LMS (curricula, assignments, training records, compliance monitoring, reporting); validated/GxP systems preferred
- Strong communication, interpersonal, organizational, and project management skills; ability to collaborate and influence across functions
- Analytical/problem-solving skills, attention to detail, continuous-improvement mindset; ability to manage multiple priorities independently
- Audit/regulatory inspection/investigation/CAPA support experience preferred
Benefits
- 401(k) with employer match; 12 weeks paid parental leave; up to 12 weeks living organ/bone marrow leave; equity incentive plans; health plans; life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays