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Ardelyx, Inc. · 8 hours ago

Executive Director, Quality Operations

Newark, CA

Full-time

Onsite

Director/Executive

$270K/yr - $330K/yr

15+ years exp

Ardelyx, Inc. is a publicly traded commercial biopharmaceutical company focused on developing innovative medicines for unmet medical needs. The Executive Director of Quality Operations will lead all aspects of Quality Operations, ensuring compliance and overseeing quality processes for product development and commercialization.

BiotechnologyHealth CareMedical

Comp. & Benefits

Responsibilities

Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to Ardelyx Quality Policies and procedures

Support the development of a proactive quality systems culture throughout the business

Establish a high-performing team to drive organizational goals & objectives and instill a robust quality culture

Drive engagement to ensure personnel have clear expectations, appropriate tools and information, and opportunity to share, grow and develop and team members are recognized for their contributions

Ensure adequate and compliant investigations into OOT/OOS results generated at contract test labs

Ensure compliance with applicable post market requirements for annual stability testing of designated batches as per commitment to regulatory agency

Partner with Technical Operations and Regulatory Affairs on development projects, method and process transfer/optimization and validation program requirements

Establish data trending programs across products to proactively identify and investigate trends and report trending outcomes at Quality Management Review and other forums

Drive systemic process change as a result of deviations/investigations and other quality trends

Help define department objectives to align with corporate goals

Keep management informed on product quality and other concerns such as supplier Quality issues, deviations

Assure appropriate systems and processes are in place for assessing product impact, investigation, follow up and closure of deviations and audit observations

Sponsor quality and technical projects with third party suppliers; collaborating with internal stakeholders and GxP partners to facilitate resolution of quality and technical issues

Evaluate and approve compliance documentation including regulatory filings for Ardelyx products

Collaborate with Ardelyx international business partners as needed

Develop budget forecasts and track QA expenses

Qualification

Quality AssuranceAnalytical QualityUS FDA regulationsStatistical analysisRegulatory submissionsCoachingTrainingRisk-based approachInterpersonal skillsCommunication skillsProblem-solving

Required

Bachelor's degree with 15+ years of related experience, preferably in life sciences with a minimum of ten years of Quality Assurance and Analytical experience in development and commercial programs

Must have strong expertise in US FDA regulations and guidance with a strong emphasis on compliance and direct experience with regulatory submissions

Strong analytical skills including trend and statistical analysis

Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership

Strong interpersonal skills to provide coaching, training, and direction

Proven experience influencing across the organization to improve product or processes

Proven ability to identify Quality issues/discrepancies through a risk-based approach and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner

Knowledge of Regulations, 21CFR 210/211, ICH Guidelines

Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment

Must have strong written and communication skills

Ability to travel domestically and internationally up to 15%

Preferred

Experience with hosting, leading and managing US regulatory agency inspections

Benefits

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

At least 11 paid holidays

Company

Ardelyx, Inc.

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.

Founded in 2007

Fremont, California, USA

201-500 employees