Sharp Corporation
Director Global Training and Content Delivery
Sharp Corporation, Allentown, Pennsylvania, United States, 18103
SUMMARY:
Sharp is seeking an experienced and strategic global leader in cGMP Regulatory Compliance Training to join our team. This leader will oversee regulatory compliance training programs for cGMP (Good Manufacturing Practices) across global operations, ensuring that all relevant training meets the highest standards. The role requires a deep understanding of cGMP regulations and guidance, along with the ability to lead and implement training programs that support regulatory compliance and operational excellence. This leader will work closely with operations, quality, and regulatory teams to ensure all training aligns with Sharp standards, regulatory standards and supports continuous improvement across our operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Leadership and Strategy: o Develop and lead the global regulatory compliance training strategy and program in support of operational compliance. Act as the subject matter expert in cGMP regulatory compliance training, stay current in industry practices and regulatory requirements and guidelines to proactively address emerging compliance requirements. o Collaborate with global regulatory, quality, and operations leaders to create a cohesive cGMP regulatory compliance training program that meets international standards.
• Training Program Development: o Design, implement, and maintain a cGMP training program that aligns with regulatory requirements and operational needs. o Develop training materials, resources, and documentation that support a comprehensive understanding of cGMP compliance across the global team.
o Ensure that all training programs are accessible, relevant, and regularly updated to reflect changes in regulatory standards.
• Quality Assurance and Compliance: o Establish a robust training evaluation process to assess compliance with cGMP and identify any gaps in training and performance. o Partner with quality and compliance teams to audit training effectiveness, ensuring alignment with cGMP regulatory requirements. o Lead initiatives to continuously improve the regulatory compliance training program, including incorporating feedback and best practices from across the industry.
• Cross-functional Collaboration and Support o Collaborate with operations, quality assurance, and regulatory affairs teams to provide support for cGMP regulatory compliance training implementation. o Support any change management efforts related to cGMP regulatory compliance training requirements, including the introduction of new processes, systems, and technologies. o Act as the primary point of contact for regulatory compliance training inquiries and support the business in responding to audits and inspections.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Direct reports if any and the level of supervision.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
• Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Quality Management); advanced degree preferred. • Minimum 8-10 years of experience in cGMP compliance, regulatory training, or quality management within a regulated industry (e.g., pharmaceutical, biotechnology, medical device). • Proven experience designing and implementing global regulatory compliance training programs • In-depth knowledge of cGMP and global regulatory requirements, including FDA, EMA, and ICH guidelines. • Strong leadership and project management skills, with the ability to influence and drive change across multiple departments. • Excellent communication skills, both written and verbal, with the ability to convey complex regulatory concepts in a clear, concise manner. • Certifications in training, regulatory affairs or quality management (e.g., RAC, CQE) are a plus. • Experience with Learning Management Systems (LMS) and other training platforms. • Strong analytical and problem-solving skills.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to perform tasks within close proximately to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions. Travel between Sharp US and overseas sharp facilities as needed. Occasional travel to clients and/or vendors facilities.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Sharp is seeking an experienced and strategic global leader in cGMP Regulatory Compliance Training to join our team. This leader will oversee regulatory compliance training programs for cGMP (Good Manufacturing Practices) across global operations, ensuring that all relevant training meets the highest standards. The role requires a deep understanding of cGMP regulations and guidance, along with the ability to lead and implement training programs that support regulatory compliance and operational excellence. This leader will work closely with operations, quality, and regulatory teams to ensure all training aligns with Sharp standards, regulatory standards and supports continuous improvement across our operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Leadership and Strategy: o Develop and lead the global regulatory compliance training strategy and program in support of operational compliance. Act as the subject matter expert in cGMP regulatory compliance training, stay current in industry practices and regulatory requirements and guidelines to proactively address emerging compliance requirements. o Collaborate with global regulatory, quality, and operations leaders to create a cohesive cGMP regulatory compliance training program that meets international standards.
• Training Program Development: o Design, implement, and maintain a cGMP training program that aligns with regulatory requirements and operational needs. o Develop training materials, resources, and documentation that support a comprehensive understanding of cGMP compliance across the global team.
o Ensure that all training programs are accessible, relevant, and regularly updated to reflect changes in regulatory standards.
• Quality Assurance and Compliance: o Establish a robust training evaluation process to assess compliance with cGMP and identify any gaps in training and performance. o Partner with quality and compliance teams to audit training effectiveness, ensuring alignment with cGMP regulatory requirements. o Lead initiatives to continuously improve the regulatory compliance training program, including incorporating feedback and best practices from across the industry.
• Cross-functional Collaboration and Support o Collaborate with operations, quality assurance, and regulatory affairs teams to provide support for cGMP regulatory compliance training implementation. o Support any change management efforts related to cGMP regulatory compliance training requirements, including the introduction of new processes, systems, and technologies. o Act as the primary point of contact for regulatory compliance training inquiries and support the business in responding to audits and inspections.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Direct reports if any and the level of supervision.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
• Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Quality Management); advanced degree preferred. • Minimum 8-10 years of experience in cGMP compliance, regulatory training, or quality management within a regulated industry (e.g., pharmaceutical, biotechnology, medical device). • Proven experience designing and implementing global regulatory compliance training programs • In-depth knowledge of cGMP and global regulatory requirements, including FDA, EMA, and ICH guidelines. • Strong leadership and project management skills, with the ability to influence and drive change across multiple departments. • Excellent communication skills, both written and verbal, with the ability to convey complex regulatory concepts in a clear, concise manner. • Certifications in training, regulatory affairs or quality management (e.g., RAC, CQE) are a plus. • Experience with Learning Management Systems (LMS) and other training platforms. • Strong analytical and problem-solving skills.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to perform tasks within close proximately to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions. Travel between Sharp US and overseas sharp facilities as needed. Occasional travel to clients and/or vendors facilities.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.