Our client is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider our client. We currently have an exciting opportunity available for a Manager, Training and Development in Boca Raton, Florida!
Responsibilities
Attend leadership meetings as a training representative.
Develops, implements, and maintains a robust training program for preceptors and Training Coordinators.
Ensures the annually competency evaluations of center staff occur timely, is an accurate determination of performance, and is executed correctly.
Develop and implement performance evaluations to ensure staff are competent on daily job responsibilities.
Ensure training records are being maintained and accurate at all times as a part of inspection readiness.
Work closely with Quality Assurance (QA) and leadership to determine training and re-training needs.
Communicats regularly with leadership on the status of training activities.
Responsible for the successful completion of New Hire Orientation (NHO) across the organization.
Travel required up to 50% of the time to the various centers.
Conduct training audits to ensure inspection readiness.
Maintain the eQMS as a training lead.
Promote a culture of quality and operational excellence and ensuring the advancement of the company’s mission and values.
Utilize adult learning principles to design, create and develop learning solutions to meet learning objectives and accommodate a variety of learning styles.
Develop and deliver engaging learning solutions that produce the desired outcomes in responding to the learners needs, including hybrid and virtual learning through a variety of media (i.e. videos, PowerPoints, demonstrations, etc.) Experience in Camtasia, Adobe Premiere Pro, iMovie, WellSaid Labs, etc., preferred)
Lead training team members in critical thinking problem solving. Create and facilitate training and development, learning initiatives, and training curriculum for specific roles and departments.
Perform gap analyses to identify opportunities to continuously improve the training program and evaluate effectiveness of training programs to address areas of deficiency (as needed).
Review and improve standard operating procedures and training programs used across the organization.
Assist other functional areas in developing training materials associated with departmental SOPs and policies.
Coordinate and lead cGMP training program, and other annual trainings, ensuring all employees receive required training, including instructor led training.
Participate in development of training metrics to maintain compliance.
Provide feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
Oversee job-specific departmental training to ensure program appropriateness and compliance. Assess programs for effectiveness and initiate improvement plans where necessary.
Act as a Training SME for all employees at all levels of the organization.
Coordinate and perform any additional activities or projects assigned.
Act as a mentor for new hires and trainees alike including peers.
Lead initiatives in improving training programs across the company including but not limited to corporate, business and manufacturing areas.
Lead by example and act as a role model for setting the standard within the Training Department.
Act as team lead in the absence of Senior Manager or Training Director
Qualifications
Minimum Bachelor of Education degree with a training and development focus; Master’s degree preferred.
Minimum of 5-7 years experience in Manufacturing, Compliance, Quality Assurance, Quality Control, or Healthcare environment with at least 2 years leading training initiatives and continuous improvement in an FDA regulated environment.
As a part of our Compliance and cGMP initiatives, employees are responsible for ensuring compliance with all Client Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Compliance, Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as Compliance, QA, HR, or EH&S depending on the issue.
Knowledge of FDA regulations for the pharmaceutical industry preferred.
Detail-oriented with expert Microsoft Office skills, including Word, Excel, Project, Visio and PowerPoint.
Proficiency in Learning Management Systems (LMS) or electronic Quality Management Systems (eQMS) administration such as Soft Expert preferred.
Excellent oral and written communication skills with the ability to design meaningful content for training classes.
Able to read complex regulations and SOPs, and transfer the information into tailored training materials.
Must be able to prepare and effectively deliver presentations to small and large groups. Excellent influencing and interpersonal skills with an ability to communicate with all levels of employees with varying degrees of education and experience.
Contact with all levels of employees to report and discuss compliance related issues and trends and perform cGMP training.
External: Contact with clients, contract manufacturers, and suppliers for compliance-related activities. Contact with various regulatory inspectors to provide information.
Makes decisions consistent with specific approved procedures and guidelines.
Makes recommendations for solutions to training issues.
Requires maintaining integrity of timelines to successful completion.
Negotiating and resolving interpretations regarding application of Client and regulatory agency requirements. Aligning the training program across various locations with the training at Boca Raton, FL.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Human Resources
Industries
Staffing and Recruiting
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