JOB SUMMARY: The Talent Development Manager is responsible for the development and implementation of the site’s learning, training, and development strategy in both GMP and non-GMP spaces. The Talent Development Manager will monitor training programs, processes, and tools to enhance employees’ skills and performance, including the oversight of resources assigned to train and transfer knowledge throughout the GMP areas. This is both a strategic and hands-on role; with duties ranging from day-to-day tactical support to program creation and delivery. You will use your expertise, toolkit, and credibility to partner closely with leadership and onsite SMEs to facilitate effective knowledge transfer to drive human performance within a compliant structure. ESSENTIAL DUTIES / RESPONSIBILITIES: Training Strategy Implemented Effectively •Lead, develop and implement the new training system/structure for Rochester site’s GMP areas. •Establish and lead an internal content development capability, creating scalable, compliant, and performance-focused training assets leveraging site SMEs. •Internal curriculum architecture •Standardized content templates and instructional standards •SME content extraction methodology •Learning design governance •Content review and approval process (especially for GMP content) •Building internal instructional design capability within team •Facilitate and manage all aspects of new hire training beginning with Orientation and Onboarding of new hires, providing them with all the training needed to enhance their effectiveness and understand the organization’s people’s practices and processes. •Manage the end-to-end training development process, including training design, content, tools, and delivery. •Provide management and direction of the resources assigned to or support training including supervision of any directly assigned staff and oversight of the activities performed by indirectly assigned staff. •Participate in the oversight and maintenance of the site electronic Learning Management System. •Develop, maintain, and report metrics designed to provide leading and lagging indicators of the performance of the Training System and training effectiveness. •Create, review, and/or approve documentation such as standards, procedures, reports, and training materials associated with implementation and subsequent maintenance of the training system. •Once implemented, maintain the training system and the associated elements in accordance with current regulatory requirements and industry standards. •Partner with HR HSE Director and Rochester Leadership Team to prepare the annual training budget for the site. Training Needs and Solutions Identified and Prioritized •Work with the site management and leadership teams to identify and prioritize training needs, provide workable solutions, and manage costs. •Work with managers to identify the gap between current performance (at either the individual, process, or department levels) and desired performance. Recommend solutions where training is the appropriate activity to close the gap. •Partner with QA during inspections •Represent training system during FDA/DEA audits •Own responses related to training observations (483s if applicable) •Design, implement, and continuously improve a structured OJT framework for GMP/GDP-regulated operations, including qualification pathways, task-level certification, trainer qualification, and audit-ready documentation. •Role-based qualification matrices •Task-level training breakdowns •Trainer certification process (“Train the Trainer”) •Structured observation checklists •OJT documentation aligned with 21 CFR 210/211 •Retraining triggers (deviations, CAPAs, audit findings) •DEA-specific handling certification (if controlled substances are involved) •Training Governance Framework •Standardization across GMP vs. non-GMP spaces •Training risk assessment methodology •Make-vs-buy content decisions •Change control impact assessments on training Improved Organizational Capabilities •Pipeline of Leadership Talent in Key Roles: Ensures processes are in place for unleashing the full potential of others by providing needed resources, coaching, experiences, and other support to place the right people in key roles and continuously upgrade their skills and knowledge. •Serve as strategic advisor to site leadership on workforce capability risks, succession exposure, and development investment priorities. •Employees Aligned to Vision, Culture and Goals through learning and development activities and design: Aligns priorities with the direction and priorities of the broader organization. Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization. Breaks down organizational silos, bridges communication gaps, and engages the employees they manage so the entire workforce can understand how the company operates and how each person can contribute to the company’s success. •Champion Change Innovation: Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. Initiates, sponsors, and implements organizational change. •Build training systems in FDA-inspected environments. •Qualification matrices •Experience implementing 9-box talent frameworks •Experience leading calibration discussions •Leadership competency model ownership •Tiered leadership curriculum (Frontline, Mid-level, Senior) •First-time manager onboarding •Coaching skills development •High-potential acceleration tracks Talent Strategy that Supports Business Goals •Partners with business leadership define the impact of strategic business objectives on people’s requirements and develops HR strategies and initiatives that support achievement of business objectives. •Partners with senior managers to ensure appropriate identification of current and future leadership needs, high potential employees, performance expectations and competencies. •Assists managers in developing or maintaining skills necessary to drive high employee performance and appropriately communicate achievement and improvement opportunities to employees. •Drives best practices around the design and implementation of effective roles, structures, and management systems. Provides for the assistance, plans and procedures necessary to define individual jobs, objectives and standards, and performance reviews across the organization. •Directs a process of organizational development that primarily addresses succession planning. Makes recommendations to senior management. HR Systems, Metrics, Interfaced Implemented Effectively •Bringing issues and changes for which training is not the solution into other HR processes, such as job descriptions, organizational structure, performance management, etc. •Participate in periodic HR processes, such as performance management, in a timely and effective manner. •Assist with leader development. •Key metrics and insights •Internal promotion rate to key roles •Bench strength metrics •% successors identified for critical roles •Leadership readiness scores •Speed to competency and skill level achievement •Other measurements/metrics/deliverables •% of roles with ready-now successors •HiPos with documented development plans •Improvement rates post-PIP •Manager compliance to review cycles People Leadership Talent Management Responsibilities • Provide direct leadership and oversight of assigned staff, including performance management, annual performance evaluations, ongoing coaching, mentoring, and goal setting. • Conduct regular managerial touchpoints with supervisors and team members to reinforce expectations, increase engagement, and support individual and team development. • Partner with Human Resources to support workforce planning, staffing needs, interviewing, and selection of qualified candidates. • Actively participate in succession planning and organizational development initiatives, identifying high-potential talent and development opportunities within the manufacturing organization. • Support onboarding, training, and ongoing development to ensure employees are equipped to meet operational, quality, and compliance expectations. • Demonstrate flexibility and responsiveness to meet evolving business needs and HR-driven initiatives, including staffing adjustments, talent reviews, engagement efforts, and change management activities. • Foster a culture of accountability, inclusion, engagement, and continuous improvement through consistent leadership presence and communication.