Quality Supervisor

Otsuka ICU Medical•Austin, TX

26d•Onsite

About The Position

The Quality Supervisor leads and directs the Change Control, GxP Auditing, and Supplier Quality groups. This role ensures all site Change Control, Documentation, GxP Auditing, and Supplier Quality adhere to domestic and global GxP regulatory standards, company policies, and customer requirements. The supervisor will mentor staff, drive risk-based methodologies and continuous improvement initiatives, act as a Subject Matter Expert (SME) during regulatory inspections and foster a culture of quality and collaboration across departments to achieve operational excellence.

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 manufactures.
Prior experience with compliance assessments, audits, and inspection process.
High level of attention to detail and the 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.
Must have strong analytical and problem-solving skills to address complex issues related to change control.
Must have 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.).
Must have proven experience with various computer software applications to track and trend quality metrics.
Must demonstrate good interpersonal skills as well as a strong general business aptitude and ethics.
Must be able to utilize logic to influence others at all levels within the organization.
Must possess strong organizational and problem-solving skills.
Must have strong written and verbal communication skills.
Must be 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.
Bachelor’s degree STEM (Science, Technology, Engineering, Mathematics) from an accredited college or university is required.
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.
Must be at least 18 years of age.
Must pass pre-employment drug screen and background check.

Nice To Haves

Creation or operations experience in a wide variety of change control systems is preferred.

Responsibilities

Supervise the change control, documentation GxP audits, and supplier quality systems.
Ensures GMP changes are consistent with established policies, procedures, and cGMPs.
Provides quality oversight and guidance for managing changes, ensuring consistency and clarity throughout the process.
Ensures site changes relating to Austin processes are reviewed for impact and Austin commitments are appropriately tracked to completion.
Ensures consistency and compliance of changes with regulatory requirements (FDA CFR, Health Canada, ICH, etc.).
Evaluates process/procedure/specification/drug changes as necessary.
Drives continuous improvement of departmental processes.
Responsible for quality reviews of validation records for local validated systems and processes; shared responsibility with quality groups.
Ensures Change Control Review Board (CCRB) occurs at a specified frequency to discuss and make decisions on change control content, deliverables and any issues that arise.
Guides decisions on risk and classifications of change control records and change control deliverables required to complete a required change.
Leads the Plant QA Specialists for review and approval of product, process, labeling, facilities, utilities and equipment related SOPs, specifications, and drug changes.
Provides supervision, leadership, training, and mentoring for guiding decisions and technical oversight for daily activities of the department.
Leads GxP Audit team with improving the internal audit program and schedule.
Provides guidance to audit teams (Internal/External), handling non-conformances, ensuring compliant documentation, staying current on regulations, and preparing for inspections.
Ensures quality compliance and assurance processes related to suppliers and ensuring that all incoming materials and regulatory processes meet the Company’s quality standards.
Leads Supplier Quality team with evaluating and selecting suppliers based on quality performance, capabilities, and risk assessments.
Provides 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 to drive continuous improvement initiatives.
Participates in the creation, implementation, and qualification of current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines.
May evaluate supplier exception reports and proposed Supplier Change Notifications, to determine the impact to the supplier material and compliance. When applicable, work with the supplier to determine resolution.
May conduct supplier risk mitigations for materials and commodities that do not meet specifications.
May assist with creation of the annual supplier audit schedule and company audit schedule and any amendments necessary.
May provide direction and support for market field actions such as product recalls, field alerts, and market withdrawals when action involves supplier or Third-Party Manufactured product, material, or commodity defect.
May review and approve supplier validation and qualifications packages for approval to the company’s Approved Supplier List.
Develop and implement quality metrics to monitor supplier performance.
Compiles and assesses 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, highlighting trends and areas of concern.
Provide leadership, and development for all aspects of department programs for change control, documentation, supplier quality, and auditing programs including internal audits, process audits, and Good Manufacturing Practice (GMP) inspections.
Provide coaching and direction to ensure consistent execution and professional development.
Establish and maintain budgets and expenditures for the area of responsibility.
Come to agreement by managing communications through discussions and compromise.
Investigate exceptions related to the documentation or change control processes to determine root cause and appropriate corrective action(s).
Write or assist with the writing of Standard Operating Procedures.
Participate, manage, or lead special or strategic projects or initiatives in support of the business as required.
Perform other related duties as assigned or required.