QA Leader (multiple positions)

Job Description Summary

Job Description

Essential Functions / Responsibilities:

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements for medical devices and pharma products distributed by PDx (Pharmaceutical Diagnostics). Ensure that projects and products are capable and will meet specified standards. Create a Quality culture by driving compliance activities around a PDx products, site or region. Responsible for the total quality management system for the business and driving Quality metrics. Ensure quality and regulatory compliance while driving process effectiveness and efficiency. Represent GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements. Utilize technical expertise and judgement to solve problems. Leverage technical skills and analytic thinking required to solve problems. Use multiple internal sources outside of own team to arrive at decisions. Provide quality oversight and implement GDP (Good Distribution Practices) and must provide guidance and support on global product quality issues. Must direct quality initiatives that accomplish continuous improvement programs to make the quality systems more efficient. Work with cross-functional teams like logistics, customer service, sales, Pharmacovigilance (PV) and commercial teams to work on route qualification studies, complaints, QA agreements, new customer selection workflow and foster a quality culture within the organization. Be a SME (Subject Matter Expert) on product disposition and regulatory compliance operations wherever GE products are manufactured, distributed, and marketed. Coordinate product release activities with internal and external teams, globally and cross functionally. Review and perform product quality related deviations, investigations, complaints, change controls, Corrective and Preventive Actions (CAPA), Supplier Corrective Action Report and Effectiveness Verification (EV) of quality events. Represent and support product quality in regulatory agency audits and perform supplier/carrier and warehouse audits, whenever needed. Prepare metrics and presentation updates to management on product quality related issues. Leverage technical skills and analytic thinking required to solve problems. Develop risk assessment and mitigation strategies on product related issues and customer complaint investigations.

Qualifications / Requirements:

Bachelor’s degree, or foreign degree equivalent, in Pharmacy, Pharmaceutical Science or Regulatory Affairs, and 5 years of progressively responsible post-bachelor’s degree experience in a related occupation required. Employer will also accept a Master’s degree or foreign degree equivalent, in Pharmacy, Pharmaceutical Science or Regulatory Affairs, with 3 years of experience in a related occupation required in lieu of a Bachelor's degree, or foreign degree equivalent and five years of progressively responsible post-bachelor's degree experience as described above. The position also requires: 3 years of experience in quality leader oversite with Quality Assurance experience in medical device and/or pharmaceutical space. 3 years of experience in representing quality in working with cross-functional teams in a global matrix organization. 3 years of experience with Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), or Good Manufacturing Practices (GMP). 3 years of experience with batch record review, QC data review, in process controls, temperature excursions, stability and release of the product. 3 years of experience in managing QMS (Quality Management System) records such as deviations, investigations and change controls. 3 years of experience in implementation of GMP/GDP quality standards, policies and procedures and ensure that the documentation and processes are complete and compliant with industry regulations and standards, globally. 3 years of experience in working with any electronic document, inventory and QMS systems. Travel may be required for supplier/warehouse and carrier audits. Role is 100% remote. Telecommuting permitted. Position reports into the company headquarters.  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). As a federal government contractor, GE HealthCare may in the future be required to have U.S. employees fully vaccinated against COVID-19. Some GE HealthCare customers currently have vaccination mandates that may apply to GE HealthCare employees.

Salary range: $149,843-$170,280 per year.

For U.S. based positions only, the pay range for this position is $149,843-$170,280 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 location. In 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 Eligibility Qualifications:

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). As a federal government contractor, GE HealthCare may in the future be required to have U.S. employees fully vaccinated against COVID-19. Some GE HealthCare customers currently have vaccination mandates that may apply to GE HealthCare employees.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal 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

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