Supplier Quality Engineer – Investment Castings
GE Aerospace
Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device
Baxter International Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $136,000 - $187,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements
- Proactively anticipate the horizon of regulations and ensure that current GCP/Clinical Trial practices reflect current and future industry practice
- Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO
- Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape
- Review and approve GQPs involving Human Subjects Research and Human Clinical Research
- Plan and monitor quality activities for Clinical Trials, including all phases of clinical trials and post-market clinical studies
- Conduct sponsor clinical sites and vendor assessments as required
- Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations
- Handle clinical escalations, non-conformances, or CAPAs related to Clinical Trial operations and/or Clinical vendors
- Manage New Supplier Request process for Clinical vendors
- Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter
- Assess impact of Field Actions on ongoing or planned clinical trials
- Interpret clinical regulations and provide guidance to Clinical Operations
- Ensure compliance with regulatory requirements, including GCP, FDA & EMEA regulations, and other relevant standards
- Serve as an interface for inspections, audits, and inspections relating to GCP compliance
- Assist in collecting quality metrics for adequate study oversight
- Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices
- Drive process improvements and initiatives in support of continuous process improvements
- Maintain current and leading-edge expertise in quality management systems and quality techniques
- Stay up-to-date with related quality legislation and compliance around clinical trials
- Travel to regulatory agencies, industry conferences, and other external meetings as required (not expected to exceed 25%)
Requirements
- Bachelor's degree in a life science or related field is required
- Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or a related field
- Experience in managing clinical quality assurance teams and developing quality management systems
- Experience in Clinical Trials, Phase 0 – IV
- Experience in Pharmaceutical and Medical Device Clinical Trials
- Experience performing laboratory, GCP, GMP audits a plus
- Strong knowledge of clinical regulations, quality management systems, and industry trends
- Ability to work independently and drive clinical quality assurance strategy and plans
- Experience with clinical data management systems and processes
- Strong leadership and communication skills
- Ability to analyze and interpret complex data
- Experience with quality management systems and auditing
Benefits
- Medical and dental coverage starting on day one
- Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP)
- 401(k) Retirement Savings Plan (RSP)
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical quality assuranceregulatory affairsquality management systemsclinical trialsGCPGMPauditingdata management systemsrisk-based approachesquality metrics
Soft skills
leadershipcommunicationindependent workanalytical skillsproblem-solvingprocess improvementteam managementstrategic planninginterpersonal skillsguidance
