Principal Training Liaison, Manufacturing

Position Summary The Principal Training Liaison – Manufacturing is the functional authority for GMP training strategy within Manufacturing, shaping the curricula frameworks, qualification standards, and workforce capability models that underpin ProKidney's clinical and commercial readiness. This role establishes the methodologies, best practices, and performance standards that define how Manufacturing develops, qualifies, and sustains a compliant, high-performing workforce. Operating at the intersection of regulatory science, adult learning, and manufacturing operations, this individual drives functional training strategy across Manufacturing and serves as a subject-matter authority and strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering. This role anticipates compliance risk, proactively architects mitigation strategies, and influences cross-functional decisions that shape site-wide quality culture and inspection readiness. The Principal Training Liaison leads through expertise and influence, mentoring senior professionals and elevating the functional capability of the Manufacturing organization. Key Responsibilities GMP Training Strategy & Program Architecture Architect and own the end-to-end GMP training strategy for Manufacturing, establishing frameworks, methodologies, and evaluation standards that define the function's approach to workforce readiness. Define the instructional model for GMP onboarding, including competency benchmarks, qualification criteria, and bootcamp curriculum design; set the standard others across the site adopt and follow. Anticipate regulatory trends and evolving GMP expectations; proactively integrate emerging requirements into training strategy before gaps materialize. Serve as Manufacturing's senior representative during regulatory inspections, agency interactions, and internal audits; shape the training-related narrative and lead responses to inspector inquiries. Establish and maintain curriculum governance processes, ensuring training content is current, SOP-aligned, and reflective of operational and regulatory requirements. Training Content Development & Functional Standards Define the standards and methodology for GMP training content development across Manufacturing, including SOP-based courses, e-learning modules, job aids, and instructor-led programs; serve as the functional benchmark for quality and effectiveness. Apply advanced instructional design principles and deep cGMP expertise to design high-impact training that drives measurable improvements in compliance, operational performance, and workforce capability. Establish a systematic training effectiveness framework — including assessment design, observational audits, and feedback mechanisms — to evaluate and continuously improve program outcomes. Deliver high-stakes, specialized instructor-led training for complex regulated operations (e.g., aseptic technique, cleanroom behaviors, advanced GMP topics) where subject-matter authority is essential. Compliance Oversight & Risk Management Define and own training compliance standards for Manufacturing; establish the metrics, governance model, and accountability structures that sustain a ≥90% training adherence rate across the site. Set and continuously optimize the qualification pathway for new hires, ensuring all personnel are trained and operationally qualified within defined timelines (target: 14 weeks from hire). Serve as the site's functional authority on aseptic technique and cleanroom behavior training, establishing the standards and qualification criteria applied across all manufacturing roles. Lead the training-related root cause analysis and CAPA development process for deviations and audit findings; anticipate systemic compliance risks and develop proactive mitigation strategies. Own the annual curriculum and job code review process, aligning training requirements with evolving role responsibilities and regulatory expectations. Cross-Functional Influence & Continuous Improvement Act as a strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering, influencing cross-functional decisions related to training, operational readiness, and cleanroom impact. Lead the training and readiness strategy for new equipment qualifications, material changes, and process introductions; shape how change is absorbed and sustained across the manufacturing workforce. Develop and own the training and operational KPI framework for Manufacturing; translate performance data into strategic insights that inform leadership decisions and drive continuous improvement. Conduct targeted floor observations and internal compliance audits; synthesize findings into recommendations that influence site-wide quality systems and operational practices. Champion and model a culture of quality, safety, accountability, and continuous improvement; shape the behavioral norms and expectations that define ProKidney's manufacturing quality culture. Trainer Development & Organizational Capability Building Define the qualification model, competency standards, and ongoing evaluation framework for GMP trainers; serve as the functional authority on trainer certification and effectiveness measurement. Architect and lead cross-functional mentorship and capability-building initiatives that elevate technical depth and instructional quality across Manufacturing and GMP functions. Drive long-term workforce capability strategies aligned with ProKidney's clinical and commercial growth trajectory; translate organizational milestones into proactive training roadmaps. Qualifications Education / Training Bachelor's degree in Life Sciences, Engineering, Education, or related field required Advanced degree (M.S., MBA, or equivalent) preferred Instructional Design certification (e.g., ATD, CPTD) or equivalent advanced experience preferred Experience 8–12+ years of progressive experience in a GMP-regulated, FDA-compliant environment (biotech, pharma, or cell therapy strongly preferred) Demonstrated track record of owning and shaping GMP training strategy and program architecture — not just program execution Deep expertise in cGMP regulations, aseptic processing, cleanroom behaviors, and regulatory inspection expectations Experience influencing cross-functional decisions and serving as a strategic consultant to manufacturing and quality functions Proven ability to anticipate compliance risk and develop proactive mitigation strategies Experience with Learning Management Systems (e.g., MasterControl) and advanced instructional design methodologies Skills & Competencies Functional authority in instructional design and advanced cGMP principles; recognized as a go-to expert within and beyond the function Strong strategic thinking and business acumen; ability to connect training outcomes to organizational and regulatory imperatives Exceptional communication, facilitation, and influencing skills across all levels of the organization, including senior leadership Ability to synthesize complex data and translate insights into strategic recommendations that drive decision-making Proven cross-functional collaboration and consultant-style engagement with partner functions Continuous improvement mindset with demonstrated ability to drive systemic, lasting change ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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