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About the Role

The Quality Supervisor leads and directs the Change Control, GxP Auditing, and Supplier Quality groups, ensuring adherence to regulatory standards and company policies. This role involves mentoring staff, driving continuous improvement, acting as a Subject Matter Expert during inspections, and fostering a culture of quality and collaboration.

Responsibilities

Supervise change control, documentation GxP audits, and supplier quality systems.
Ensure GMP changes are consistent with established policies, procedures, and cGMPs.
Provide quality oversight and guidance for managing changes.
Ensure site changes are reviewed for impact and commitments are tracked.
Ensure consistency and compliance of changes with regulatory requirements.
Evaluate process/procedure/specification/drug changes.
Drive continuous improvement of departmental processes.
Perform quality reviews of validation records for local validated systems and processes.
Ensure Change Control Review Board (CCRB) meets at specified frequency.
Guide decisions on risk and classifications of change control records.
Lead Plant QA Specialists for review and approval of SOPs, specifications, and drug changes.
Provide supervision, leadership, training, and mentoring for department activities.
Lead GxP Audit team in improving the internal audit program and schedule.
Provide guidance to audit teams, handling non-conformances, ensuring compliant documentation, and preparing for inspections.
Ensure quality compliance and assurance processes related to suppliers.
Lead Supplier Quality team in evaluating and selecting suppliers.
Provide guidance and oversight to the Supplier Quality team for developing supplier quality strategies, directing supplier audits, managing supplier relationships, assessing quality agreements, assessing the ASL, and collaborating with cross-functional teams.
Participate in the creation, implementation, and qualification of programs, policies, processes, procedures, and controls.
Evaluate supplier exception reports and proposed Supplier Change Notifications.
Conduct supplier risk mitigations for materials not meeting specifications.
Assist with creation of the annual supplier audit schedule and company audit schedule.
Provide direction and support for market field actions involving supplier or Third-Party Manufactured product defects.
Review and approve supplier validation and qualifications packages.
Develop and implement quality metrics to monitor supplier performance.
Compile and assess site metrics for inclusion into Management Review.
Drive initiatives such as root cause analysis and corrective action plans for quality issues.
Prepare quality reports for management.
Provide leadership and development for change control, documentation, supplier quality, and auditing programs.
Provide coaching and direction for consistent execution and professional development.
Establish and maintain budgets and expenditures for the area of responsibility.
Manage communications through discussions and compromise to reach agreement.
Investigate exceptions related to documentation or change control processes.
Write or assist with writing Standard Operating Procedures.
Participate, manage, or lead special or strategic projects.
Perform other related duties as assigned or required.

Requirements

Thorough understanding of Pharmaceutical Quality Systems and Subsystems.
Thorough knowledge and understanding of cGMPs, FDA, Health Canada, ISO, ICH and/or pharmaceutical industry guidelines.
Direct experience reviewing and approving changes, deviations, corrective and preventive action plans, and efficacy checks for GMP changes, audit and inspection-related records and documents.
Direct experience with change control and documentation.
Experience with external suppliers and third-party manufacturers.
Prior experience with compliance assessments, audits, and inspection process.
High level of attention to detail and ability to prioritize and manage complex and heavy workloads in a dynamic environment.
Effective skills collaborating with various teams and stakeholders, including quality, manufacturing, regulatory, and research and development, for effective change management.
Strong analytical and problem-solving skills to address complex issues related to change control.
Good organizational, presentation, project management, communication, technical writing, and meeting facilitation skills.
Experience with QMS systems.
Understanding of investigation techniques including problem solving methodology (5 Whys, DMAIC, etc.).
Proven experience with various computer software applications to track and trend quality metrics.
Demonstrate good interpersonal skills as well as strong general business aptitude and ethics.
Able to utilize logic to influence others at all levels within the organization.
Strong organizational and problem-solving skills.
Strong written and verbal communication skills.
Able to work and adapt in a fast-paced environment.
Extensive knowledge of auditing principles, methodologies, and best practices.
Proficient in gap assessments, audit planning, and identifying compliance risks.
Extensive knowledge of internal auditing principles, methodologies, and best practices.
Familiarity with global regulatory agency trends, notified body requirements, and systemic improvement processes.
Must be at least 18 years of age.
Must pass pre-employment drug screen and background check.

Skills

Change Control
GXP Auditing
Supplier Quality
cGMP
FDA
Health Canada
ISO
ICH
QMS systems
Problem-solving methodology (5 Whys, DMAIC)
Quality metrics tracking and trending
Auditing principles
Gap assessments
Audit planning
Risk identification

Location

Site based

Work Type

Full-time

Experience Level

5-7 years of Quality compliance experience (Pharmaceuticals, Biopharmaceuticals or Biologics) across functions such as engineering, manufacturing, regulatory, quality, R&D in an FDA regulated industry.
Minimum of two (2) years supervisory experience.

Education Level

Bachelor’s degree STEM (Science, Technology, Engineering, Mathematics) from an accredited college or university is required.

About the Company

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
Each product we make helps ensure patients receive the therapies they need without disruption.
When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
Join us and help shape the future of IV solutions.

Equal Opportunity

Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
We are committed to providing equal access and opportunities for all candidates.