QA Specialist II - III (CSV)

Description

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx's first approved product for the treatment of irritable bowel syndrome with constipation (IBS-C) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.

Quality Assurance Specialist II - III (CSV)

Purpose of the Role

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 interal) 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 incolve 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 Responsibilites:

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)

The anticipated annualized base pay range for this full-time position is $70,200 to $85,800. 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 match, 12 weeks of paid parental leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision) and basic life insurance and disability, as well as up to 10 hours of paid vacation per month, and at least 10 paid holidays.

Ardelyx is an equal opportunity employer.