Sr Mgr, Training & Document Management

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

This position is in a pharmaceutical manufacturing plant that operates 24/7.  This role is that of a working manager, where the individual is expected to both lead individuals and participate in the day to day operations/tasks of the Training and Document management departments.  

Works with site business partners to identify and address the Document Management process and training program needs for the Waco operations. This role will define and manage the overall Document Management and training program, as well as its interactions, which will include but not limited to strategy oversight, defining training requirements, and tracking training completion and effectiveness.

Provides administration oversight for the Document Management System and the electronic learning management system (ELMS), along with guidance to improve document management and training methodologies to align with current industry best practices.

This position is responsible for the following:

• Providing directing strategic principles to a lean Document management process ensuring its simplification and on time delivery.
• Developing and providing oversight over the training program and its effectiveness. Ensuring training program is fit for the purpose.
• Determining appropriate metrics regarding training compliance to all regulatory requirements, along with training effectiveness measurements to gauge the effective transferal of the appropriate knowledge and skills.
• Structuring onboarding training program from a quality compliance perspective and partnering with other departments for the remaining required training.
• Creating and maintaining appropriate process to ensure document management and training are executed in parallel.
• Providing oversight and assisting in the development of cGMP training materials for all cGMP related positions in accordance with the Quality System Regulations requirements as outlined in 21 CFR, Part 820, 210 & 211, Good Manufacturing Practices, ISO 13485:2003, and other applicable regulations.
• Ensuring the delivery and effectiveness of the annual periodic cGMP training.
• Providing oversight and assisting in the development of additional training requirements and materials as needed (including but not limited to on the job training).
• Providing oversight and assisting in the development and administration of the Qualified Trainer Program for all personnel identified to deliver standardized training.
• Providing direction and oversight of the Waco document management and training team with regard to daily job responsibilities, departmental projects and support assignments as required.
• Ensuring the timeliness of GMP training activities to meet current business needs.
• Assisting site management with industry best practices and strategies to ensure employee qualification along with meeting all current training requirements.
• Defining training requirements, qualifications and its effectiveness and providing oversight over aseptic room behaviors. Delivering appropriate training and ensure its effectiveness.

Qualifications

Essential Knowledge, Skills & Abilities

• Demonstrated knowledge of the principles of adult education and the ability to verbally and visually present information in a group setting.
• Demonstrated knowledge of cGMP/QSR requirements preferred.
• Experience with the development of Computer-Based Training (CBT).
• Experience with Electronic Learning Management Systems.
• Experience with Human Performance Improvement techniques.
• Experience with train the trainer development and facilitation.
• Experience with root cause analysis methodologies is preferred.

Education & Experience

• Master’s Degree in science or equivalent professional certification(s) is preferred, with at least 5 years of experience in managing the training program and/or document management in a Pharmaceutical industry; or a BA/BS degree with at least 10 years managing the training program and/or document management in a GMP regulated industry.
• Prior experience developing and executing training and/or document management strategies/programs for large groups of employees in a pharmaceutical industry.
• Training experience in a aseptic cGMP environment preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.