Specialist II, Compliance Services
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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
This role supports the organization’s compliance framework by developing, maintaining, and executing compliance activities related to documentation management, Learning and Development (L&D) initiatives, supplier quality, and Private Label Distributor support. This role is responsible for preparing, reviewing, and maintaining accurate compliance documentation, supporting training content and delivery to promote regulatory awareness, and assisting in supplier and distributor compliance activities to ensure alignment with applicable regulations, internal policies, and quality standards. Partners cross-functionally to help identify and mitigate compliance risks, supports monitoring and audit readiness activities, and contributes to the continuous improvement of compliance processes to ensure ethical, consistent, and compliant business operations.
This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.
Duties & Responsibilities
Supports Documentation and L&D
- Collaborates with HP US Supply and Quality colleagues and process owners to create, maintain, and implement accurate procedures.
- Evaluates the impact and completion of local implementation of applicable corporate procedures.
- Manages completion of assigned system-related tasks.
- Serves as backup for the HP US Supply and Quality document management system, supporting the full documentation lifecycle.
- Acts as backup for authoring, revising, and reviewing Policies, Standard Operating Procedures, Work Instructions, and other controlled documents to ensure accuracy, completeness, and compliance.
- Acts as backup for Learning and Development system administration, including assignment of training curricula to employees, contractors, and temporary staff to support compliance.
- Acts as backup for generating and distributing reports from the L&D system.
Supports Supplier Management
- Manages supplier CAPAs, including initiation, tracking, follow-up, and closure.
- Supports Quality Assurance Agreements with suppliers and partners, including document review, routing, and approval.
- Performs supplier audits as required in accordance with internal procedures and audit plans and supports follow-up on audit findings, corrective actions, and preventive actions.
Third-Party Supplier Services (Repackaging Operations)
- Acts as backup Quality contact and secondary point of contact for resolving repackaging-related quality issues.
- Reviews and approves master repackaging documents, product specifications, and related quality documentation in accordance with procedures and quality agreements.
- Coordinates authorization of component shipments to repackaging sites, ensuring all required quality checks and approvals are completed prior to release.
- Performs SAP quality transactions related to repackaging, including documentation, status updates, and material movements.
- Reviews completed batch records and repackaging documentation to support authorization of finished product shipment back to BIPI.
- Collaborates with Quality, Supply Chain, and Operations to support supplier oversight, issue resolution, and inspection readiness.
Supports Private Label Distributor (PLD) Quality Oversight
- Manages and maintains Quality Assurance Agreements with assigned PLDs in alignment with regulatory requirements and internal quality system procedures.
- Provides routine oversight of PLD compliance with QAA requirements and escalates issues as needed.
- Serves as the primary point of contact for PLD quality communications, including deviations, complaints, change controls, and other quality system activities.
- Coordinates PLD-related change controls within the electronic change management system, ensuring required documentation, assessments, and approvals are completed.
- Supports investigation and documentation of PLD quality events by collecting information, tracking actions, and ensuring timely follow-up.
- Collaborates cross-functionally to maintain inspection readiness and support continuous improvement through trend analysis and process updates.
Requirements
- Bachelors degree in a scientific or technical discipline (e.g. Pharmaceuticals, Chemistry, Engineering)
- Other degree focus may be acceptable with appropriate experience.
- 0-5 years of experience supporting projects and general quality systems.
- Experience within regulated environment, such as pharmaceuticals, medical devices, etc., is desired.
- Knowledge of FDA regulations and guidances around cGMPs.
- Experience with business systems like SAP.
- Possesses excellent communication skills with the ability to interact effectively with cross-functional teams.
- Ability to travel as needed (up to 25%).
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.