US_Sr. AD, Regulatory Compliance & Training

Description

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 several 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.

The Senior Associate Director, Regulatory Compliance & Training will set training standards globally and act as a Divisional Management System Owner for regulatory training in US, Germany, and Japan. This role will lead, plan, and organize centralized compliance training program in R&D. The incumbent will design and manage training systems and business processes that meet strategic business goals and state, federal and international regulatory requirements as well as develop training curriculum, analyze data and align training tools to enable effective learning which meet quality and regulatory objectives. This role will serve as NBE/ATMP USDA shipping permit holder and process owner for R&D.

Duties & Responsibilities

• Serves as Divisional Management System Owner responsible for compliance related training in US, Germany and Japan.
• Establishes and directs business processes that will provide centralized oversight of R&D regulatory training initiatives and assure training activities are conducted & documented by qualified trainers.
• Sets and analyzes training requirements and determine needs for R&D based on knowledge of FDA, USDA, DEA, regulations.
• Maintains Awareness of industry practices and regulatory trends and evaluate implications and requirements for R&D.
• Meets with Q Dev management and review audit findings to focus training on specific department needs.
• Identifies, selects and continuously improves learning tools including classroom lectures, seminars, media based, e-learning, documentation systems, the Learning Management System.
• Determines training resource requirements including staff, consultants and external trainers, e-learning, and other costs.
• Prepares, obtains approval and manages training budget.
• Manages and develops direct reports.
• Maintains network of department training coordinators and provides guidance and direction.
• Ensures departmental trainers are qualified.
• Establishes and directs business processes for training, documentation, and reporting with departmental activities; aligns with global process teams to manage LOS training system.
• Provides centralized oversight of R&D regulatory training initiatives.
• Manages local role-based SOPs/training concept.
• Ensures global documents are properly identified and assessed for R&D applicability
• Leverages R&D training processes/resources with other cross-divisional initiatives (Medical, GFE, IT).
• Leads regulatory requests related to training during inspections; serve as a responsible person for any regulatory or Corporate findings related to training function; monitor development training KPIs.

Requirements

• Master’s Degree with seven (7) years pharmaceutical experience (or equivalent).

OR

• Bachelor's Degree with ten (10) years pharmaceutical experience (or equivalent).
• Minimum of five (5) years training management experience.
• Knowledge of FDA (GLP/GMP/GCP), USDA, EU, DEA requirements including current trends and industry practices.
• Requires active participation in professional and trade associations, tracking of literature and publications and on-going benchmarking.
• Experience in the design and management of cross-functional business systems and processes.
• Knowledge of adult learning principles and learning tools (e.g., LMS, e-learning, PowerPoint) and ability to design courses.
• Exceptional public speaking and other communication skills.
• Ability to manage and develop direct reports and to have cross-functional influence on trainers and training coordinators.

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 $163,000 and $248,000.  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.