(Archived) Quality Assurance Senior Training Specialist

Description

We are seeking someone to support our Boehringer Ingelheim Pharmaceutical, Inc. (BIPI) Research and Development (R&D) training by executing end-to-end training management from course development through implementation and recording keeping. Act as a subject matter expert with the learning management system, providing guidance and support to the R&D community on regulated activities (Good [Laboratory, Clinical, Manufacturing] Practices (GxP) and USDA) and documentation in these validated systems (learning management and document management). Provide instructional design support and content development (e-learning, classroom, and on-the-job (OJT)) for R&D course content.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Responsible for training/teaching new and existing personnel in GxP, quality systems, and/or hands on techniques as required by regulations. Support and train trainers and lead training liaisons to support the training function. Maintain knowledge of current regulations (e.g. AWA, FDA) and monitor regulatory trends to provide updated training content and communications and enable contemporaneous training administration and regulatory compliance.
• Maintain training systems such as the learning management system to ensure accurate and prompt capture of training events and records. Produce learning metrics/key performance indicators (KPIs) from the learning management system, as well as audit reports for inspection readiness.
• Responsible for strategic instructional design concepts in the development of training courses, e-learnings, gamification, and other learning methodologies to address current regulatory trends and quality issues, or general training concepts. Stay abreast of learning and digital training technology (i.e. Articulate).
• Represent the training function as a delegate in the face of audits/inspections, continuous process improvement projects and requests for information and act in the absence of the US Head of Regulatory Compliance & Training. Identify areas of potential process improvement resulting from training that is not effective. Be an active participant in corrective actions. Assist and step in as necessary the US Head of Regulatory Compliance Training in support of global initiatives.
• Maintain training tools (i.e. Data Entry, Job Descriptions, Training Plans) within training group and evaluate effectiveness of current processes. Assist junior training specialists when necessary.

Requirements

• Bachelors degree in Science, Communications, or Business from an accredited institution, plus seven (7) years of experience in the pharmaceutical industry; Or
• Masters degree in Science, Communication, Business from an accredited institution, plus five (5) years of pharmaceutical industry experience.
• Experience with learning managements systems (experience with SuccessFactors a plus), report generation, and training metrics/KPIs.
• Experience with instructional design frameworks and tools (i.e. Articulate or similar programs).
• Knowledge of adult learning principles.
• Excellent communication (written/verbal) skills
• Experience providing training in a highly regulated environment to diverse stakeholders..
• Knowledge of FDA (GLP/GMP/GCP), USDA (AWA), EMA, and DEA requirements.
• Active participation in professional and trade associations.
• Ability to work on global teams, which may require meeting outside of standard business hours.

Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Compensation Data

This position offers a base salary typically between $120,000 and $205,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.