Senior Manager GxP Training

Alvogen Emerging Markets Holdings Limited; Morristown (NJ); On-site; USD 104,000 - 128,000; Full time

Benefits offered by this job

Medical and prescription drug coverage

Retirement savings program

Paid time off (176 hours per year)

Wellness program

Job summary

Alvogen Emerging Markets Holdings Limited is seeking a Senior Manager GxP Training in Morristown, NJ. This role focuses on designing and overseeing GxP training programs to ensure regulatory compliance and technical proficiency within the organization.

Ideal candidates will have a bachelor’s degree, 5+ years of experience in the pharmaceutical sector, and strong project management skills. The position offers a competitive salary and comprehensive benefits.

Qualifications

• Bachelor’s degree in Life Sciences, Human Resources or related field required.
• Minimum 5 years' experience in training and development within pharma or healthcare.
• Practical working knowledge of cGxP and experience with regulatory audits.

Responsibilities

• Design and oversee GxP training programs for Alvogen.
• Manage the GxP Learning Management System to track compliance.
• Evaluate training effectiveness and adjust curricula accordingly.

Skills

Communication skills

Project management

Knowledge of cGxP requirements

Experience with LMS platforms

Education

Bachelor’s degree in Life Sciences, Human Resources or related Field

Master's degree (preferred)

Tools

Learning Management System (LMS)

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regular Full-Time Morristown, NJ, US

9 days ago Requisition ID: 2094

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

Primary responsibilities of this role include the following:

1. GxP Training program/curricula design, development and maintenance

a. 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.

b. Together with Alvogen sites, oversee the GxP compliance onboarding curriculum for new employees & continuing education.

c. 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.

2. Delivery & Facilitation

• 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.

3. Assessment & Evaluation

• 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

Salary Range: $104,000 to $128,000 annually.

Benefits include 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.