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Senior Quality Training Specialist
Job Location:
Job Location:
Waltham, MA - USA
Monthly Salary:
$ 119000 - 145000
Monthly Salary:
Posted:
24 August 2026 (12 days ago)
Posted:
Application Deadline:
21 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
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:
- Bachelors 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 $119000 - $145000. 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 Companys career site without a valid signed search agreement signed by Companys 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.
Required Experience:
Senior IC
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
