Vice President, Analytical Development & Quality Control

United States·Walthamexecutive

OtherQuality Control

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Overview

Key Responsibilities

Partner with other functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturing Lead and collaborate with other…

Requirements Summary

15+ years pharmaceutical industry experience, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role, or equivalent experience Proven track record of successful…

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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 has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

Position Summary:

The Vice President, Analytical Development & Quality Control is the enterprise leader accountable for Ardelex’s analytical chemistry activities. Reporting to the Chief Technical Operations Officer, the VP of AD/QC will provide oversight of Ardelyx’s array of contract testing laboratories across the company’s portfolio of development-stage projects and commercial products. The VP of AD/QC will build, improve, and scale a modern, inspection ready analytical chemistry capability that ensures reliable supply, strengthens compliance, and champions a proactive, high-engagement technical and quality culture across internal teams and external partners.

Responsibilities:

Partner with other functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturing
Lead and collaborate with other departments to implement quality and process improvement initiatives
Oversee the development, validation, implementation, and life-cycle management of analytical methods for the analysis of raw materials, intermediates, drug substance, and drug product
Ensure that all AD/QC activities are conducted in stage-appropriate accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements
Author and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and Stability
Manage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence, innovation, collaboration, and teamwork
Develop and maintain productive relationships with outsourced analytical testing partners, actively managing all associated activities
Allocate internal and external resources effectively to meet departmental and corporate timelines and objectives
Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department
Collaborate with QA in the preparation and presentation of reports to management on quality-related metrics and compliance status

Qualifications:

15+ years pharmaceutical industry experience, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role, or equivalent experience
Proven track record of successful collaboration with key stakeholder functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs)
In-depth knowledge of current regulatory requirements and guidelines for analytical development and quality control (cGMP, ICH, FDA, etc.)
Direct experience as a lead author of relevant Module 3 sections and supporting regulatory authority inspections
Experience with computerized systems (e.g. LIMS, Veeva, etc.) and their associated compliance requirements
Strong technical problem-solving and decision-making skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization

Work Environment:

The position is based in our Waltham, MA office and requires onsite presence 2-3 days per week.
The ability to travel to Ardelyx’s other locations and external testing labs is required (up to 20 %)

The anticipated annualized base pay range for this full-time position is $302,000 - $370,000 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.