Director, Quality & Regulatory Business Development
GE HealthCare
full-time
Posted on:
Location Type: Office
Location: Arlington Heights • Illinois • Wisconsin • United States
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Salary
💰 $142,400 - $213,600 per year
Job Level
About the role
- Executes against the Quality & Regulatory Business Development Process.
- Scheduling, preparation, execution, reporting, and follow-up activities associated with Business Development activities.
- Identification and communication of high-risk issues.
- Reporting compliance concerns and recommended improvements to business leadership.
- Developing and ensuring strategy is executed to current industry practices and regulatory expectations.
- Standardization of processes, tools, and performance management system.
- Requires ability to lead functional teams or projects with indirect resources.
Requirements
- Master’s Degree and a minimum of 7 years’ experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of 9 years’ experience in the medical device or pharmaceutical industry; or will consider a High School Diploma and a minimum of 13 years' of progressive responsibility in the medical device or pharmaceutical industry.
- Minimum of 5 years’ Experience driving Global programs to resolve quality compliance issues (directly).
- Experience with Pharma QMS requirements and regulatory requirements including but not limited to FDA 21 CFR Part 211 & 212, Eudralex and PICS.
- Demonstrated ability to lead programs/projects.
- Ability to document, plan, market, and execute programs.
- Established project management skills.
- Demonstrated ability to analyze and resolve problems.
- ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt).
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life insurance
- Disability insurance
- Tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality & Regulatory Business Development ProcessPharma QMS requirementsFDA 21 CFR Part 211FDA 21 CFR Part 212EudralexPICSproject managementproblem analysisprogram executionprocess standardization
Soft skills
leadershipcommunicationorganizational skillsproblem-solvingplanningmarketingexecutionteam leadership
Certifications
ASQ CertificationCQECQALean Certificationgreen beltblack belt