Quality Supervisor

ICU Medical•Austin, TX

25d•Onsite

About The Position

The Quality Supervisor leads and directs the Change Control, GxP Auditing, and Supplier Quality groups. The role ensures that site change control, documentation, GxP auditing, and supplier quality activities comply with domestic and global GxP regulatory standards, company policies, and customer requirements. The supervisor mentors staff, applies risk-based methodologies, drives continuous improvement, serves as a subject matter expert during regulatory inspections, and fosters quality and collaboration across departments. The position provides oversight of change control and documentation, including review of changes for regulatory and operational impact, risk and classification decisions, and completion of required deliverables. It oversees the Change Control Review Board, quality review of validation records, and review and approval of relevant SOPs, specifications, and drug changes. The role also leads internal and external audit activities and supplier quality programs, including supplier evaluation, audits, quality agreements, approved supplier list assessments, supplier performance metrics, and collaboration on improvement initiatives. Additional responsibilities include supporting quality programs and controls, supplier-related market actions, management review metrics, root cause analysis and corrective action plans, quality reporting, department budgets, investigations, SOP writing, and strategic projects. The position is site-based, with audit-related travel expected less than 15% of the time. The work is largely sedentary in a professional office environment, with occasional lifting up to 25 pounds and occasional travel for supplier audits or training.

Requirements

Bachelor’s degree in a STEM field from an accredited college or university.
5–7 years of quality compliance experience in pharmaceuticals, biopharmaceuticals, or biologics within an FDA-regulated industry.
At least two years of supervisory experience.
Thorough understanding of Pharmaceutical Quality Systems and subsystems.
Thorough knowledge of cGMPs, FDA, Health Canada, ISO, ICH, and/or pharmaceutical industry guidelines.
Direct experience reviewing and approving changes, deviations, corrective and preventive action plans, efficacy checks, and audit- or 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 inspections.
Experience with QMS systems.
Understanding of investigation techniques and problem-solving methodologies such as 5 Whys and DMAIC.
Experience using computer software applications to track and trend quality metrics.
Extensive knowledge of auditing principles, methodologies, and best practices, including internal auditing.
Proficiency in gap assessments, audit planning, and identifying compliance risks.
Familiarity with global regulatory agency trends, notified body requirements, and systemic improvement processes.
Strong analytical, problem-solving, organizational, project management, presentation, communication, technical writing, and meeting facilitation skills.
Ability to prioritize and manage complex, heavy workloads in a dynamic, fast-paced environment.
Ability to collaborate with quality, manufacturing, regulatory, research and development, and other stakeholders.
Strong interpersonal skills, business aptitude, ethics, and ability to use logic to influence people at all organizational levels.
Must be at least 18 years of age.
Must pass a pre-employment drug screen and background check.

Nice To Haves

Creation or operations experience with a wide variety of change control systems.

Responsibilities

Supervise the change control, documentation, GxP auditing, and supplier quality systems.
Ensure GMP changes comply with established policies, procedures, cGMPs, and applicable regulatory requirements.
Provide quality oversight and guidance for change management, including review of change impacts and tracking site commitments to completion.
Evaluate process, procedure, specification, and drug changes as necessary.
Drive continuous improvement of departmental processes.
Review quality records for local validated systems and processes, in coordination with other quality groups.
Ensure the Change Control Review Board meets at the specified frequency and guide decisions about change risk, classifications, content, and deliverables.
Lead Plant QA Specialists in reviewing and approving relevant product, process, labeling, facilities, utilities, and equipment SOPs, specifications, and drug changes.
Provide departmental supervision, leadership, training, mentoring, technical oversight, and professional development.
Lead the GxP Audit team in improving the internal audit program and schedule; guide audit teams, non-conformance handling, compliant documentation, and inspection preparation.
Oversee supplier quality and lead supplier evaluation and selection based on quality performance, capabilities, and risk.
Guide supplier quality strategies, supplier audits, supplier relationships, quality agreements, Approved Supplier List assessments, and cross-functional improvement initiatives.
Participate in creating, implementing, and qualifying programs, policies, processes, procedures, and controls to ensure product quality and regulatory compliance.
Evaluate supplier exception reports and proposed Supplier Change Notifications and, when applicable, work with suppliers to determine resolution.
Conduct supplier risk mitigation for materials and commodities that do not meet specifications.
Assist with creating and amending annual supplier and company audit schedules.
Provide direction and support for supplier- or third-party-manufactured-product-related recalls, field alerts, and market withdrawals when applicable.
Review and approve supplier validation and qualification packages for inclusion on the company's Approved Supplier List.
Develop and implement quality metrics to monitor supplier performance and compile site metrics for Management Review.
Drive root cause analysis and corrective action plans for quality issues and prepare quality reports for management.
Lead department programs for change control, documentation, supplier quality, audits, and GMP inspections.
Establish and maintain budgets and expenditures for the area of responsibility.
Manage communications and reach agreement through discussion and compromise.
Investigate documentation or change control exceptions to determine root causes and appropriate corrective actions.
Write or assist with writing Standard Operating Procedures.
Participate in, manage, or lead special and strategic projects as required, and perform other related duties as assigned.