The Senior Training Manager-QA is responsible for the strategic development, implementation, and continuous improvement of the company's GxP training and personnel qualification program to ensure compliance with current Good Manufacturing Practices (cGMP) and global regulatory requirements. This role oversees the design and execution of training systems, curricula, and qualification processes to ensure that all personnel are appropriately trained, qualified, and competent to perform their roles.

The Senior Training Manager partners cross-functionally with Quality Assurance, Manufacturing, Quality Control, and other departments to ensure training programs are aligned with regulatory expectations, quality system requirements, and business objectives. This position plays a critical role in inspection readiness by ensuring training programs are risk-based, role-specific, effective, and fully compliant.

Duties and Responsibilities (Responsibilities include but are not limited to):

• Lead the development and continuous improvement of the company's GxP training and personnel qualification program, ensuring alignment with regulatory requirements and internal quality standards
• Oversee and administer training systems (LMS/eQMS), ensuring accurate training assignment, tracking, compliance, and data integrity across all functions
• Ensure inspection readiness of all training programs, including leading training-related activities during regulatory inspections and audits and defending training processes
• Establish and maintain role-based training curricula and competency frameworks, including training effectiveness strategies and performance-based qualification
• Drive cross-functional collaboration and continuous improvement, ensuring training programs are integrated with quality systems (deviations, CAPA, change control) and aligned with business and regulatory expectations

Supervisory Duties:

• This position does not have supervisory responsibilities.

Education/Experience/Skills:

• BS/BA in life sciences, education, or related field required
• Minimum of 3-5 years of experience in a regulated (GxP) environment, with significant experience in training, quality systems, or personnel qualification programs
• Demonstrated experience developing and managing training programs in a pharmaceutical or biotech environment
• Strong knowledge of cGMP requirements, regulatory expectations (FDA, EMA), and applicable training requirements (e.g., personnel qualification)
• Experience with Learning Management Systems (LMS) and/or electronic Quality Management Systems (eQMS)
• Strong understanding of quality systems (e.g., deviations, CAPA, change control) and their linkage to training
• Demonstrated knowledge of quality risk management principles (ICH Q9) and their application to training programs
• Proven leadership and cross-functional collaboration skills
• Strong analytical skills, including the ability to trend data and evaluate training effectiveness
• Excellent communication and presentation skills

Working Environment and Travel:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
Occasional travel may also be expected, as needed.