Quality Assurance Manager

24 hours ago

Indianapolis, Indiana, United States Baxter Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Baxter. As a Quality Assurance Manager, you will be responsible for leading the coordination of all activities of the Quality Compliance team, ensuring compliance, product quality, and conformance to regulations and Baxter quality policies.

Key Responsibilities
  • Manage the activities of the Regulatory Intelligence department in the Quality organization, ensuring results in terms of compliance, product quality, performance, and safety.
  • Plan, implement, and follow up on audits and FDA inspections, ensuring conformance to regulations.
  • Develop and improve quality systems procedures related to site regulatory compliance.
  • Participate in or run quality assessments of internal operations and suppliers to analyze compliance and assess risk.
  • Identify and lead continuous improvement projects to achieve quality, reliability, and cost improvements.
  • Interact frequently with subordinate supervisors and functional peer group managers.
  • Develop and manage the budget for the compliance team, ensuring adherence to the budget.
  • Manage, coach, engage, train, and develop direct reports.
Requirements
  • Bachelor's degree (Science or Engineering preferred).
  • 10+ years' demonstrated experience in Quality, Compliance, Manufacturing, Engineering, or related field.
  • 5+ years of management experience preferred.
  • Past experience as an FDA Inspector preferred.
  • Independent Certifications desired (e.g. CQA, ASQ, RAPS).
  • Thorough knowledge of applicable procedures, specifications, regulations (CFR Parts 210, 211, and 820) and standards.
  • Subject Matter Expert in current Good Manufacturing Practices (cGMP) and auditing.
  • Strong technical, analytical, judgment, and problem-solving skills.
  • Ability to lead/supervise a team of employees.
  • Ability to build relationships across functional boundaries at multiple levels internally/externally.
  • Excellent verbal and written communication skills, including presentation skills.
  • Strong courage of conviction, conflict resolution, interpersonal, and influencing skills.
  • Demonstrate multitasking, project management, and execution skills.
What We Offer
  • Medical, Dental, and Vision coverage.
  • 160 hours of Paid Time Off and Paid Holidays.
  • 401K match.
  • Employee Stock Purchase Program.
  • Paid Parental Leave.
  • Tuition Reimbursement.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. Individual pay is based on location, skills, and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

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