Director, Quality Systems

Otsuka ICU Medical•Austin, TX

1d•Onsite

About The Position

The OCNA Director Quality Systems will from the ground up build, implement, and maintain a robust Pharmaceutical Quality System (PQS) in compliance with cGMP, ICH Q10, and local regulatory standards (e.g., FDA, Health Canada, Texas Department of State Health Services) for a new pharmaceutical manufacturing facility. This role is responsible for the “hands on” development of the site quality organization, establishing Quality Control (QC) and Quality Assurance (QA) functions, and ensuring all facility, equipment, and production processes are validated and compliant before commercial launch.

Requirements

Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university is required: BS Science/Technology/Engineering/Mathematics (STEM).
Minimum of 15 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above, with at least 5 years in a senior leadership capacity in the Pharmaceutical or Medical Device industry, with direct experience in establishment of Quality Management Systems from startup.
Experience: Strong leadership, risk-based decision-making, and project management experience. Proven experience in quality systems and quality systems deployment and improvement for new or existing pharmaceutical facilities.
Technical Knowledge: Expertise in ISO standards, regulatory requirements (e.g., cGMP, ICH Q10, FDA, Health Canada), and risk management for pharmaceutical manufacturing.
Analytical Skills: Strong ability to analyze data, identify root causes, and solve problems.
Communication: Excellent verbal and written skills to interact with all levels of the company, vendors, and customers. Proactive, “can-do” attitude to address quality and compliance challenges.

Responsibilities

QMS Implementation & Setup
Develop and implement a comprehensive Pharmaceutical Quality Management System (PQS) from scratch.
Lead the design, development, project planning, deployment, maintenance, and improvements of the QMS system, procedures, and policies for the new facility.
Create and approve the facility Quality Manual, Quality Policies, and SOPs, ensuring alignment with global regulatory standards (e.g., FDA 21 CFR Parts 210 & 211, Health Canada GUI-0119, Texas Department of Health State Services).
Establish QMS modules to standards: Document Control, Change Management, CAPA, Deviation Management, Supplier Quality, Training.
Implement electronic QMS (eQMS) systems for efficiency and data integrity.
Validation & Technology Transfer
Provide quality oversight for facility qualification (IQ/OQ/PQ) and utility validation.
Ensure validation of computer systems, analytical methods, and manufacturing processes (process validation) before commercial launch.
Ensure all quality standards for validation and technology transfer meet compliance and regulatory standards.
Regulatory Inspection Readiness
Prepare the site for pre-approval inspections (PAI) and regulatory authority audits (FDA, EMA, etc.).
Host audits and manage the timely closure of all regulatory commitments.
Function as the primary liaison with regulatory agencies on quality matters.
Quality Operational Leadership
Oversight and management a diverse team of quality individuals to establish and maintain a Pharmaceutical Quality System for the new facility.
Chair critical quality boards: Management and CAPA review boards.
Facilitate and review annual product quality reviews (APQR).
Responsible for the site QA/QC budget and resource planning.
Culture & Team Development
Recruit, train, and mentor the Quality team (QA/QC personnel) in alignment with company strategy and goals.
Promote a "Quality First" culture across the site, ensuring high compliance awareness across the team (e.g., Quality, Production, Engineering, etc.).