Associate Director, QA Engineering - Combo Products

Unither Pharmaceuticals

92d • Onsite

About The Position

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. You bring a wealth of Quality Assurance knowledge to the table and are eager to build and grow a QA team around you. You're able to pivot at a moment's notice between utilizing your individual expertise and mentoring or developing a member of your team. 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. Responsibilities for this role also include oversight and leadership of the Change Control, Quality Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits.

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 in quality assurance, quality engineering and management in the FDA regulated environment or a related industry 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
• Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines
• 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
• Clear understanding of US FDA, EU, and JP GMP regulations
• Knowledge of software validation practices and data integrity initiatives
• Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), solid oral dose, biologics operations, medical devices, and combination products
• 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
• Able to work independently with occasional to no need for guidance
• Strong organizational skills and strong attention to detail

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
• Knowledge of software validation practices and data integrity initiatives

Responsibilities

• Work independently and as part of a multi-functional team to manage, lead, and prioritize workloads, complex projects/tasks, departmental initiatives, and deadlines
• Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved
• 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 (e.g., Research and Development, Manufacturing, Validation, Regulatory Affairs, etc.). 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. Responsible for evaluating new technologies against applicable guidance, and industry practices
• Provide support during external, internal, and health agency audits
• Author, collaborate, analyze, and approve cGxP related documents (i.e., product/ design specifications, computerized systems, validation protocols and reports (IOQ/PQ), analytical/microbiological method validations, stability protocols, operational protocols and reports, Site Master Files, DHF, DMR, etc.) for accuracy, completeness, and compliance with cGMP and UTC policies, procedures, and requirements
• Participate in supplier selection process and specification reviews as necessary
• Participate in, and/or lead, quality system, process and product-related decisions. Recommend and manage changes to policies and establishes procedures affecting immediate function/group
• Collaborate with different members of the QA/RA departments working on special projects
• Manage, lead, and support quality system project initiatives and continuous process verification. Through continuous oversight, identify gaps and coordinate resolution, and quality improvement initiatives
• 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

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees