Quality Executive, PDx

GE Healthcare•Waukesha, WI

6d•$240,000 - $360,000•Remote

About The Position

This position will serve as the Quality Executive for the PDx business, partnering with business leaders to ensure patient safety, product quality, operational excellence, and compliance with the company's Quality Management System (QMS) as well as all applicable pharmaceutical regulations and standards (such as FDA 211,212, cGMP, EMA, ICH, Q9/Q10). The individual will lead the Quality team and collaborate cross-functionally—including extensive partnership with Contract Manufacturing Organizations (CMOs)—to achieve quality objectives throughout the product lifecycle.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or related scientific discipline; advanced degree preferred.
Minimum of 10 years of quality assurance experience in the pharmaceutical industry, with at least 5 years in a leadership role.
Strong knowledge of US and international pharmaceutical regulations and standards (e.g., FDA, EMA, ICH, WHO).
Demonstrated experience managing quality for products manufactured at external partners or CMOs, including technical transfer, quality agreements, and oversight of CMO performance.
Proven ability to lead and influence cross-functional teams in a matrixed environment.
Experience leading regulatory inspections and third-party audits, with a track record of successful outcomes.
Excellent communication, analytical, and problem-solving skills.

Nice To Haves

Advanced degree (Master's or PhD) in a relevant field.
Certification in Quality (e.g., ASQ, Six Sigma, ISO lead auditor) is an asset.
Experience with sterile manufacturing, biologics, and/or advanced therapy medicinal products (ATMPs).
Proficiency in developing and managing quality agreements, change controls, and deviation/CAPA processes with CMOs.
Demonstrated commitment to fostering a strong quality culture and continuous improvement environment.

Responsibilities

Develop and communicate the Quality vision for the Pharmaceutical Diagnostics business, translating this vision into clear strategies, priorities, and actionable plans.
Work closely with senior leadership teams and functional partners to deliver on patient safety and product quality objectives, ensuring alignment with business goals and regulatory requirements.
Oversee and ensure compliance with the company's QMS and all applicable global and regional pharmaceutical regulations and standards (e.g., FDA 21 CFR Part 211, 212, EMA GMP, ICH Q9/Q10).
Provide quality oversight for all internal manufacturing operations as well as external Contract Manufacturing Organizations (CMOs), ensuring adherence to company standards and regulatory expectations.
Establish and monitor key performance indicators (KPIs) across the entire product lifecycle, from development and New Product Introduction through commercial manufacturing to End of Life.
Ensure inspection readiness at all relevant sites, including company facilities and partner CMOs.
Lead and support regulatory inspections (FDA, EMA, MHRA, etc.) and third-party audits, and manage timely and effective responses to any findings.
Stay current on regulatory changes affecting pharmaceutical quality compliance; assess potential business impact, develop appropriate mitigation strategies, and execute plans to minimize business disruption.
Foster a culture of quality and continuous improvement within the organization and across CMO partnerships.