Sr. Supervisor Quality Compliance

Baxter International Inc. • Irvine, CA

2d • Onsite

About The Position

At Baxter, every person deserves a chance to live a healthy life, a belief that has guided the company since 1931. Baxter is redefining healthcare delivery to make a greater impact today, tomorrow, and beyond, with colleagues united by the Mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration. Individuals are empowered to take ownership and make a meaningful impact, striving for efficient and effective operations and accountability for exceptional results. This role offers purpose and pride. The Sr. Supervisor Quality Compliance will supervise and coordinate activities across multiple sections or departments within the Quality organization, ensuring product quality and compliance with regulations and Baxter quality policies. This individual will serve as a thought leader, subject matter expert, and coach on various quality systems elements, driving excellence in quality management, including Document and Change Control Process, Training, Quality Management Review, Change Review Board, internal, corporate/external audits and regulatory inspections, audit readiness, PROSite Model and Risk Management, and projects. The position ensures the suitability and effectiveness of the Irvine Quality Systems and compliance with applicable domestic and international regulations, directives, and standards.

Requirements

• Bachelor’s degree in engineering, Science or related field.
• 3+ years of Quality, Manufacturing, Engineering or related field which should include 2+ years of NCR/CAPA experience.
• 1-2 years of supervisory experience.
• Experience of coordinating and supporting Document Control, Internal Audit, CAPA and Non-conformance.
• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong analytical and problem-solving skills.
• Ability to manage/supervise a team of employees.
• Good interpersonal/communication/influencing/negotiation skills.
• Strong command of problem-solving techniques and ability to coach others in their application.
• Good project management skills.
• Must be able to write clearly and informatively, edit work for spelling and grammar, presents numerical data effectively, able to read and interpret written information.
• Good communication skills- able to speak clearly, listen and get clarification, present information to internal audience and regulatory bodies’ auditors.
• Working knowledge of FDA quality system regulations.

Responsibilities

• Oversee the daily operations of a section or department, ensuring product quality, performance, and safety meet regulatory requirements and company standards.
• Develop, implement, and maintain quality systems procedures to ensure compliance with regulatory requirements and company standards within the section or department.
• Develop, maintain, and update inspection documentation procedures to ensure compliance with product regulations and company standards.
• Coordinate site audit-readiness activities, including internal, corporate and external audits and regulatory inspections, to ensure compliance and assess risk within the organization.
• Coordinate and facilitate site inspections by regulatory agencies and Notified Bodies and serve as the primary point of contact during inspections.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; address any issues or concerns that may arise.
• Identify opportunities for process improvements and implement changes to enhance efficiency, productivity, and quality within the organization.
• Collaborate with the Quality organizations and site to achieve business targets and meet key performance indicators (KPIs).

Benefits

• comprehensive compensation and benefits packages
• medical and dental coverage that start 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), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• 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
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior