DescriptionAs 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 Quality Document Management Specialist III will act as a Document Management Specialist for SOPs, other GxP documents, and archived records generated by the Development organization. This role will conduct activities supporting document management and archiving operations. The incumbent will provide guidance and expertise to colleagues on the processes and systems for document management and archiving. The position holder will proactively identify, interpret, and define document management needs and improvements that fulfill compliance and business requirements.Duties & Responsibilities
Contributes to the management of the on-site archive.
Accountable for the receipt, indexing, storage, retention, and retrieval of records submitted to the archive.
Responsible for supporting strategic management, efficient operation, and overseeing processes that enable effective preservation, access to, and security of digital and paper archives.
Provides controlled document support by managing the document life cycle in the electronic Document Management System (eDMS).
Manages workflows, facilitates the use of appropriate document types and technical formats.
Executes the periodic review process.
Collaborates with document owners and cross-functional teams to ensure quality standards are met.
Regularly communicates with internal customers to keep them informed.
Writes and reviews SOPs as necessary to ensure compliance, efficiency, and clarity.
Provides expertise in records management and preservation of electronic records.
Participates in local and/or global working groups, task forces, projects related to electronic records and digital information.
Automates and improves processes using AI/digital tools.
Serves as a Subject Matter Expert (SME) on eDMS, advises document owners on good documentation practices and Boehringer Ingelheim standards, and executes various document management service components.
Provides end user training on document management processes and systems.
Utilizes the system's reporting capabilities to develop and generate reports to leverage knowledge and support compliance metrics.
Proposes enhancements and is a key participant in the testing and implementation of additional functionality within eDMS.
Participates in and contribute to inspection readiness activities.
Acts as a point of contact for audit questions related to the archive and document management during internal, corporate, and regulatory authority inspections.
Resolves straight forward to complex observations noted during audits/inspections.
Requirements
Master’s degree from an accredited institution with three-plus (3+) years or equivalent experience in related field.
OR
Bachelor’s Degree from an accredited institution with seven-plus (7+) years or equivalent experience in related field.
Onsite/Flex : This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Demonstrates knowledge of document lifecycle management and archiving processes and systems (e.g., Veeva Vault Quality, FileTrail) including regulatory and compliance requirements
Previous experience in pharmaceutical industry and knowledge of GLP/GMP regulations is a plus.
Proficiency in Microsoft Office 365 tools and knowledge of other tools (e.g. Power Apps etc.)
Requires minimal supervision in applying new technology and concepts and evaluating and implementing new electronic tools.
Independent problem detection and ability to implement problem solving solutions for strategic benefit.
High degree of attention to detail.
Ability to find errors or inconsistencies that others may miss.
Demonstrates the ability to write standard documents and align with systems both locally and globally.
Excellent written and verbal communication skills.
Ability to communicate outside of Development to Legal, IT and other functions.
Excellent conflict resolution and negotiation skills.
Strong organizational skills resulting in the ability to be self-directed and manage multiple projects.
Ability to interact effectively with individuals at all organizational levels.
Ability to troubleshoot and resolve application issues.
Ability to work independently and provide support to peers.
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 DataThis position offers a base salary typically between $90,000.00 and $147,000.00 USD. 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 (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards) .Eligibility RequirementsMust 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 olderAll qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
