Senior Quality Training Lead — GxP & Compliance Learning

Ardelyx; Waltham (MA); Hybrid; USD 119,000 - 145,000; Full time

Benefits offered by this job

401(k) with employer match

Paid parental leave (12 weeks)

Organ and bone marrow leave (12 weeks)

Equity incentive plans

Health plans (medical, prescription, 3

Dental and vision insurance

Life insurance and disability

Flexible time off

Winter holiday shut down

11 paid holidays

Job summary

Ardelyx is seeking a Senior Quality Training Specialist to lead the development, administration, delivery, and continuous improvement of the Quality Training program within the QMS. The role partners with Quality, SMEs, and stakeholders to ensure staff have the knowledge and skills to meet procedures, regulatory requirements, and company standards.

The position is hybrid-based with 2–3 days onsite at the Waltham, MA headquarters.

Qualifications

• 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.
• 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
• 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 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

Skills

Training delivery

Adult learning principles

GxP

Quality Management Systems

LMS experience

Communication

Project management

Analytical thinking

Audits experience

Education

Bachelor's degree in life sciences or related

Tools

LMS (Learning Management System)

Job description

Ardelyx is seeking a Senior Quality Training Specialist to lead the development, administration, delivery, and continuous improvement of the Quality Training program within the QMS. The role partners with Quality, SMEs, and stakeholders to ensure staff have the knowledge and skills to meet procedures, regulatory requirements, and company standards.

The position is hybrid-based with 2–3 days onsite at the Waltham, MA headquarters.