The Director, Quality Assurance will be responsible for leadership of a functional team as well as individual contributions to establish quality operations for ProKidney located in Winston Salem NC. This role will manage and execute GMP quality assurance activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Essential Duties and Responsibilities:

• Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
• Oversight of Aseptic processing, environmental monitoring program, and technical transfers between development/GMP including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations
• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions
• Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing
• QA oversight of equipment/facility/utility validation and requalification program and validation master plan
• Review protocols, data summaries, reports for stability studies
• Ensure compliance with current U.S. and EU cGMP regulations and industry standards
• Manage the inspection readiness program at the site to ensure site is always inspection ready and manage the logistics of any corporate, external or Health authority inspections at the site
• Manage the internal and external audit program
• Facilitate the site quality council, providing timely and metric driven updates on the status of quality systems for management reviews and other leadership forums
• Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction
• Provide input for continuous improvement of corporate quality systems
• Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner
• Perform risk assessments of new programs for entry into the GMP facility
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
• Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role
• Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems
• Ensures quality staff assesses and approves change controls
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
• Establish, educate, and enforce standard operating procedures required under GMP.
• Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature.
• Maintain a state of readiness for and participate in audits and inspections.
• Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing

Knowledge and skills (general and technical) preferred:

• Quality Assurance experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility
• Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
• Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
• Knowledge of GMP, GCP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy productsDenonstrated ability to lead on-site corporate, external or Health authority inspections.
• Strong knowledge of current industry trends and the ability to use the latest technologies
• Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.
• Strong leadership skills with the ability to thrive in a high throughput environment
• Ability to lead and manage projects/teams within corporate objectives and project timelines
• Successful in mentoring people managers
• Collaboration / Teamwork / Conflict Management

Preferred Experience and Skills:

• Biologic or cell therapy manufacturing and/or analytical testing
• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.
• Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
• Ability to identify, focus, and solve problems in a timely and efficient manner.
• Experience with quality audits and EU regulatory inspections.
• Experience or working knowledge of R&D or clinical supply areas and processes

Qualified, interested candidates should send resume to: careers5@prokidney.com