This is whereyour work makes a difference.
You will independently manage compliance audit processes and serve as a knowledgeable resource for internal audits, external inspection support, state licensing, and regulatory intelligence activities. In this role you will lead routine compliance investigations, contribute to metrics analysis and trend reporting, and support inspection readiness while mentoring junior team members on audit methodology and compliance expectations.
What youll be doing- Maintains Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
- Manages the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for audits performed.
- Prepares for and conducts internal and supplier audits by researching background information and developing assessment strategy; collects and analyzes objective evidence regarding issues and risks.
- Reports audit/inspection findings to management and evaluates audit responses, CAPA plans, and CAPA objective evidence for adequacy, including root cause determination and timeliness; escalates issues to management as appropriate.
- Manages audit files through the process to closure and performs follow-up audits to confirm CAPA effectiveness.
- Coordinates and manages state licensing program.
- Leads regulatory intelligence activities including analysis and distribution of FDA guidance, warning letters, consent decrees, and industry publications to relevant stakeholders.
- Supports external regulatory inspections including back room management, document retrieval, and commitment tracking through closure. May serve as front room host/table lead.
- Prepares management reports depicting compliance trends for Management Review purposes.
- Mentors and trains Quality Compliance Associates I and Technicians on audit methodology and compliance procedures.
- Participates in continuous improvement initiatives and quality system enhancement projects.
- Supports customer compliance activities including customer audits and customer regulatory information requests.
What youll bring- Candidate must not be allergic to Penicillins or Cephalosporins.
- BS in business or science or equivalent degree.
- Minimum 3 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
- Minimum 3 years of related quality auditing experience in cGMP environments; previous internal or external auditing experience required.
- ASQ CQA and/or other auditor accreditation strongly preferred.
- Extensive working knowledge of applicable quality and regulatory standards and regulations.
- Excellent communication skills both written and oral with ability to present to management.
- Must demonstrate sound judgment and analytical skills to enable assessment of risk.
- Expertise in GMP regulations and regulatory inspection processes.
- Strong organizational skills with ability to lead multiple complex projects.
- Proficiency in quality software systems (e.g., TrackWise) and MS Office applications.
- Resourceful, self-reliant, self-motivated, and confident.
- General knowledge of Lean Six Sigma and other continuous improvement tools preferred.
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 $88,000 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
