Quality Executive, PDx

Waukesha, WI - USA

Yearly Salary: $ 240000 - 360000

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

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 companys Quality Management System (QMS) as well as all applicable pharmaceutical regulations and standards (such as FDA 211212 cGMP EMA ICH Q9/Q10). The individual will lead the Quality team and collaborate cross-functionallyincluding extensive partnership with Contract Manufacturing Organizations (CMOs)to achieve quality objectives throughout the product lifecycle.

Job Description

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 companys 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.

Required Qualifications

Bachelors 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.

Preferred Qualifications

Advanced degree (Masters 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.

#LI-Remote

We will not sponsor individuals for employment visas now or in the future for this job opening. For U.S. based positions only the pay range for this position is $240000.00-$360000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer . Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: December 27 2025

Job Description SummaryThis 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 companys Quality Management System (QMS) as well as all applicable pharmaceutical reg...

Job Description Summary

Job Description

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 companys 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.

Required Qualifications

Bachelors 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.

Preferred Qualifications

Advanced degree (Masters 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.

#LI-Remote