Description

The Specialist IV, Documentation Control & Learning & Development manages learning and development system (LMS/LOS) for BIPI Columbus colleagues to ensure a state of compliance. This role drives innovative solutions to site training, troubleshoots LMS/LOS and functions as site Domain Administrator as well as maintaining Domain Administrator role to provide support as requested. The incumbent actively participates as a member of US LOS Super User team to develop, implement, monitor and harmonize best practices within LMS/LOS system throughout the HP, AH and Bio divisions within the US. This role assists with the influencing of how to use LMS/LOS within BI sites globally. Leads assigned training initiatives locally and globally to support Boehringer Ingelheim goals.

The Specialist IV, Documentation Control & Learning & Development partners with people leaders to ensure that site employees have an established curricula which supports adherence to job profiles, GMP, and role expectations. The incumbent is responsible for annual review of curricula. This role ensures site and BIPI Columbus employees who directly impact GMP activities receive training to maintain compliance to regulations for the markets in which products are sold.

The Specialist IV, Documentation Control & Learning & Development ensures quality and compliance in BIPI Columbus documentation system and processes. This role establishes, monitors and maintains system for oversight of documents and processes under Quality change control responsibility, including Policies, Standard Operating procedures, Work Instruction, master documents, service agreements and other controlled documentation throughout BIPI Columbus. The incumbent oversees the assessment of corporate policies and procedures and ensures those that impact BIPI Columbus operations are properly implemented into the affected departments' Learning curricula within the controlled document system (Learning Management System - LMS).

The Specialist IV, Documentation Control & Learning & Development creates, revises and facilitates approval of controlled documentation for BIPI Columbus within the company's documentation management system (e.g. Veeva Vault Quality). This role provides critical review of new and revised controlled documentation generated by BIPI Columbus colleagues. The incumbent partners with the site and other applicable stakeholders to ensure accurate and timely completion of controlled documents.

The Specialist IV, Documentation Control & Learning & Development acts as the site Management System Operator for documentation and learning and development.

This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.

Duties & Responsibilities

• Manages Learning Management System to ensure accurate and prompt capture of training events and records.
• Analyses and develops LMS to enable best use of the tool for the site.
• Manages the site curricula/assignment profile in a state of continuous development to ensure compliance standards.
• Ensures core compliance training programs exist to meet regulatory requirements (i.e. GMPs).
• Sets standards and expectations for core compliance training requirements and programs that align with curricula/assignment profiles.
• Determines core compliance requirements for site and aligns with departmental onboarding.
• Collaborates within MSO Network on best practices.
• Acts as local Domain Administrator as well as providing administration support/backup to other US OPUs.
• Contributor to the US LMS/LOS Super User team.
• Acts as a site representative to the Mandatory Training Governance Council for US mandatory training for the BOPU.
• Establishes, monitors and maintains a system for oversight of documents and processes under Quality change control responsibility, including policies, standard operating procedures, work instructions, master documents, service agreements and other controlled documentation throughout the site.
• Establishes and maintains a governance structure and system for procedures (i.e., authoring, revising, routing, deploying).
• Establishes, maintains and trains on a flexible governance structure with appropriate Quality oversight for non-procedural documentation (i.e. master documents, service agreements).
• Responsible for the oversight for Records Review Day.

Leads and represents site Learning & Development initiatives:

• Communicates L&D system and performance with internal and external stakeholders (e.g. during audits/inspections; business review meetings).
• Leads continuous process improvement projects and fulfills requests for information.
• Identifies and makes transparent to site management areas of potential process improvement resulting from non-effective training.
• Drives corrective action.
• Collaborate on global training initiatives as representative of the site.
• Develops, facilitates, and delivers Learning & Development courses, workshops, and site trainings.
• Collaborates with site to assign facilitators, including self, to course offerings.
• Collaborates with OPU learning organizations to facilitate shared learning programs.
• Maintains facilitator certification requirements as needed.
• Develops, facilitates, and delivers on-boarding and training for new hires.
• Acts as Local Management System Owner (LMSO) for Learning and Development systems.

Leads, facilitates and coordinates the timely, accurate and successful creation, review and implementation process for Policies, Standard Operating Procedures, Work Instructions and other controlled documentation to maintain license to operate:

• Writes/revises Policies, Standard Operating Procedures, Work Instructions and other controlled documentation.
• Collaborates with site colleagues/process owners to create and maintain accurate procedures that comply with regulatory and corporate requirements.
• Reviews sites Policies, Standard Operating Procedures and Work Instructions for accuracy and completeness.
• Evaluates impact and ensures local implementation of relevant corporate procedures.
• Manages the company document system to track documentation lifecycle (e.g. Veeva) and supports harmonization of use throughout the site as subject matter expert and key user.
• Acts as Local Management System Owner (LMSO) for Documentation system.

Requirements

• Minimum BS required, preferably in Science, Engineering, Statistics, Pharmacy or related degree.
• Minimum of five (5) years pharmaceutical experience and/or learning and development and documentation management experience.
• Minor in communication or discipline closely related to adult learning and development or related field.
• Leadership and/or project management experience preferred.
• Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with electronic document management systems and training systems (e.g. Veeva, TrackWise, SAP, EasyGenerator preferred.
• Teamwork and Collaboration with all levels within the organization globally and locally.
• Knowledge of Pharmaceutical business, including but not limited to GMP, GLP regulations.
• Knowledge of Regulatory requirements.
• Accountability for delivering results.
• Strong communication skills by different means (e.g. verbally, electronically).

Additional Skills:

• Quality Mindset
• Work with Integrity & Trust
• Customer Orientation
• Project Management
• Agility
• Analytical thinker
• Ability to maintain confidential information