Senior Manager GxP Training

Alvogen; Morristown (NJ); Presencial; USD 104 000 - 128 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical and prescription drug coverage

Dental and vision

Retirement savings program

Paid time off

Life insurance

13 paid holidays

Resumo da oferta

Alvogen is seeking a Senior Manager GxP Training to design, implement, and oversee GxP training programs, ensuring staff have necessary skills for compliance. The role involves collaboration with department leaders and continuous improvement of training curricula.

Qualifications include a Bachelor’s degree and at least 5 years of experience in training within the Pharmaceutical industry. A robust benefits package and annual bonus are provided. The anticipated salary range is $104,000-$128,000.

Responsabilidades

• Design and oversee Alvogen's GxP training system.
• Conduct GxP training needs assessments.
• Maintain up-to-date knowledge of GxP regulations.
• Manage and track compliance of GxP LMS.

Conhecimentos

Project management

Interpersonal skills

Communication skills

Knowledge of cGxP requirements

Training and development experience

Formação académica

Bachelor’s degree in Life Sciences or related field

Master’s degree (preferred)

Ferramentas

LMS platforms

Digital working tools

Descrição da oferta de emprego

Summary of Position

The Senior Manager GxP Training is responsible for designing, implementing, assigning and overseeing GxP training programs within the Alvogen organization. This role ensures that all staff involved in GxP activities have the necessary skills, technical knowledge and expertise to satisfactorily execute their responsibilities and meet compliance expectations and requirements.

Organization Structure

This position primarily interacts with Department Heads/Leads, Managers, Sr. Managers, Directors, Sr. Directors & VPs within Alvogen to support personnel training requirements. This position will report to the Chief Quality Officer.

Responsibilities

• Design, govern, oversee and continuously improve Alvogen’s GxP training system. Work with department leads to design and implement GxP training curricula to ensure that Alvogen employees have the necessary technical skills and knowledge to meet Company & regulatory expectations/requirements.
• Together with Alvogen sites, oversee the GxP compliance onboarding curriculum for new employees & continuing education.
• Ensure that training content meets GxP compliance expectations & requirements.
• Periodically undertake GxP training needs assessments to determine the skills and knowledge gaps at Alvogen, and plan training programs accordingly.
• Collaborate with IT and the LMS vendor to manage the GxP Learning Management System (LMS) and track progress & compliance.
• Perform periodic audit trail reviews of the LMS.
• Add training modules as required and applicable.
• Oversee & deliver pertinent GxP induction training and outsource delivery of specialized GxP training to designated personnel as required and applicable.
• Maintain up to date knowledge of current GxP regulations associated with personnel training & knowledge management.
• Periodically evaluate GxP training effectiveness.
• Compile data/feedback to adjust & continuously improve Alvogen’s training curricula.
• Develop, maintain & periodically present suitable key performance indicators (KPIs) showing Alvogen’s GxP training program effectiveness level.
• Maintain accurate & timely GxP training records to ensure compliance.
• Closely collaborate with departmental leads to identify training gaps or future training needs/requirements.

Qualifications & Skills

• Bachelor’s degree in Life Sciences, Human Resources or related Field (Masters preferred).
• Minimum 5 years’ working experience in training & development within the Pharmaceutical or Healthcare industry.
• Practical working knowledge of cGxP requirements.
• Practical hands‑on experience & knowledge with LMS platforms and digital working tools.
• Excellent communication, presentation and interpersonal skills.
• Strong project management and organizational skills.
• Experience working in a GxP environment & interacting with Regulatory Health Authorities and auditors during site inspections/audits.
• Experience developing e-learning tools preferred.

GMP Decision‑Making Authority

Person has responsibility to discuss, design & maintain Alvogen’s training curricula, as well as ensure that Alvogen’s LMS is effective and meets Regulatory requirements & expectations. Expected to provide governance level oversight to training development, modification, delivery, and operation of the LMS. Expected to advise and organize the deployment of other human resources engaged with the training program in various departments (i.e. dotted line responsibility).

Benefits

The anticipated base salary range for this position is $104,000-$128,000. This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts, a retirement savings program, long‑term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year.

Equal Opportunity Employer

An Equal Opportunity Employer, including disability/vets.