QA Specialist III (CSV)

Description

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as early-stage pipeline candidates.

We are seeking a highly skilled and detail-oriented QA Computer System Specialist to join our team. The ideal candidate will be responsible for overseeing the quality assurance for all GxP computer systems within our organization. The person in this role will work with the functional teams to ensure that all GxP regulated systems are purchased, audited, installed and maintained according to industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position will also support plan and organize QA activities for computer system validation projects.

Specific duties of this role include, but are not limited to, overseeing and approving validation- related documents, conducting risk assessments, determining which elements of projects should be validated, assessing and/or coordinating impact of proposed changes to computerized systems, and support activities to prepare for inspections (both external and internal) related to computer system validation. The candidate will also be responsible for maintaining GxP computer systems in a validated state in addition to support designing work processes for users and administrators of these systems.

In addition, this position will involve interacting with regulatory agencies and corporate partners during inspections and audits and may require travel to audit computerized system vendors off-site. The incumbent will also develop and implement strategies to ensure compliance with CSV requirements and consistent application of relevant policies and processes.

Position Responsibilities:

Note: The following is meant to be a representative but not necessarily all inclusive of the duties and responsibilities for this position:

• Ensure compliance with quality assurance for the implementation and validation efforts of GxP computer systems, in collaboration with the project team.

• Review and approve validation deliverables for new computer systems, including validation plans, requirement specification documents, validation protocols, test scripts, validation reports, and trace matrices.
• Maintain the validated state of all GxP computer systems, including re-validation, support change control management, periodic review, and lifecycle management.
• Responsible for the management of the GxP Computer System Inventory List
• Ensure that the control of GxP computer systems is integrated into Quality Management System
• Provide quality oversight for the migration of GxP data/records.
• Develop and implement policies, Standard Operating Procedures (SOPs), Work Instructions/Forms, and training materials for Ardelyx regulated computer systems.
• Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place
• Plan, organize, and manage the activities of external CSV contractors and/or consultants
• Represent QA CSV and participate in multi-departmental project team meetings including assisting IT department with integration of other software
• Train employees on processes and workflows associated with GxP computer systems, including inspection requirements, and promote technical development
• Perform other related duties as assigned from time to time based on company needs

Position Requirements:

• Bachelor's degree in a technical discipline, science /engineering discipline preferred but not required equivalent experience may be considered

• 1-7 years of experience in a Quality environment, with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining GxP computer systems in the Life Science Industry
• Strong understanding of CFR Title 21 (Parts 11, 210, and 211), GAMP5, Annex 11, electronic record/electronic signature, and data integrity requirements, standards and guidelines
• Understanding and familiarity with FDA regulatory requirements, guidelines, and recommendations for computerized system lifecycle management
• Ability to comprehend technical information related to computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them
• Ability to manage CSV contractors and auditors, if needed
• Experience in other Quality roles is a plus
• Excellent leadership, technical, management, problem solving and project management skills
• Organizational and management skills to handle multiple functional groups and influence others.
• Ability to speak, present data, and defend approaches in front of audiences and inspectors
• Experience and proficiency with industry standard enterprise system applications (QMS, LMS, MES, EDMS, ERP, CMMS)

Work Environment

Corporate office location in Fremont, CA. Hybrid will be considered. Willingness to travel up to 10% of time within the U.S.

As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It's the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good.

The anticipated annualized base pay range for this full-time position is $90,000-$110,00. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Actual base paywill be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include anannual 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 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.