Senior Quality Training Specialist

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

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 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

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

The anticipated annualized base pay range for this full-time position is $119,000 - $145,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.