Associate Director, QA Engineering - Combo Products

United Therapeutics Corporation • NC

92d

About The Position

United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. The Associate Director, QA Engineering will provide advanced support and subject matter technical expertise and utilize industry best practices to maintain cGMP compliance for UTC combination products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices. This role will manage and support the new product development activities through product and process development and improvement, implementation of product/process verification, validation activities, and commercialization.

Requirements

• Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline or Master’s Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline.
• 12+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Bachelor’s degree or 10+ years of experience with Master’s degree.
• 5+ years of experience leading multi-discipline engineering projects with previous participation in regulatory inspections.
• Ability to manage, mentor, and/or provide technical guidance to other engineers/project team members.
• Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards.
• Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, 21 CFR Part 11, 210, 211, and 820.
• Strong technical writing skills.
• Strong experience in regulatory inspections.
• Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheet in a network environment.

Nice To Haves

• Strong experience with validation and facility qualification.
• Experience in process development activities for manufacturing/ assembly operations.
• Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems.
• Continuous Process Validation experience.

Responsibilities

• Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation.
• Support the trending and reporting of CAPA activities.
• Lead investigations and serve as an internal expert for Risk Assessments, Quality Events, Investigations, Out of Specifications (OOS), Change Controls, Exceptional Conditions, and Corrective and Preventive Action (CAPA) processes for GxP events.
• Interact regularly with peers and senior management across multiple functional groups.
• Negotiate and manage expectations across functional groups for project timelines and quality requirements.
• Lead and manage quality engineering activities and provide SME support for project start-up and the technology transfer of new products or methods into existing manufacturing operations.
• Provide support during external, internal, and health agency audits.
• Author, collaborate, analyze, and approve cGxP related documents for accuracy, completeness, and compliance.
• Participate in supplier selection process and specification reviews as necessary.
• Coordinate and lead internal mock audits in preparation of the site readiness for health agency inspections.
• Mentor peers on technical information on projects, mock audits and recalls, and other areas of expertise.
• Direct and manage team to include responsibilities for goal setting, performance reviews/management, coaching, mentoring and career development.

Benefits

• Medical / dental / vision / prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off & paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees