Principal Specialist, Quality Operations

Description

The Principal Specialist of Quality Operations provides real-time Quality Assurance support in Operations ensuring compliance with USDA, EU regulatory requirements and BIAH procedures. Spending at least 50% of time in production, triage and investigate large-scale major deviations with potential for impact to product quality and/or impact to multiple departments such as facility or utility investigations. This role identifies and implements CAPA to prevent recurrence and drive toward Right First-Time compliance. The incumbent will coach, mentor and promote Quality Culture to ensure GMPs are appropriately followed. 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.

Duties & Responsibilities

• Provides Quality Assurance support with 50% of time spent in Operations focused on compliance with USDA, EU regulatory requirements and BIAH procedures, deviation prevention via right first-time manufacture and documentation, periodic assessments to maintain a state of audit readiness, real-time batch record review, 4-eye verification, calculations, sample control and delivery.
• Influences as a technical resource and departmental SME for Quality related questions or topics including Regulatory, Corporate, and Site-specific requirements.
• Performs full investigations of major events with potential product quality impact for complex products manufactured at BIAH to identify the root cause, impact assessment, and CAPA to assess quality requirements for compliance with USDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.
• Investigates large-scale deviations potentially impacting multiple departments such as facility or utility investigations.
• Triages real-time quality impact of events in conjunction with shop-floor employees in support of deviation management.
• Ensures impacted material is appropriately quarantined and management notified.
• Supports Deviation Risk Assessment.
• Performs operations related investigational activities as assigned in TrackWise child Investigation records in support of High-risk deviations / complaints.
• Performs review and approval of CAPAs associated with the focus area.
• Trains employees on Deviation/CAPA.
• Grants system access to employees as appropriate.
• Conducts internal audits of facility, production floor, equipment, and warehouse and provide written reports summarizing findings.
• Builds understanding and responsibility for area(s) of focus.
• Provides QA assessment and approval for Change Controls.
• Leads major projects and implements improvements in manufacturing procedures or processes as they relate to inspection readiness and Right First Time (RFT) compliance.
• Supports Quality Management activities (e.g., metrics, strategic initiatives, Quality Risk Management (QRM) assessments, Change Control assessment, Change Control closure).
• Performs trending and analysis of deviations and works with responsible area owners to identify opportunities for improvement.
• Serves as a deputy to the QA Investigations Leader in the event of personal absence.
• Supports during Regulatory / corporate audits including contributions to strategies to successfully respond to auditor concerns.
• Leads alignment of quality assurance events with functions across different areas within production (Central Services, Cells / Media Production, Active Ingredient Production, Formulation / Filling / Freeze Drying / Capping Production, and Quality Control Testing).

Requirements

• A Bachelor’s degree in a relevant scientific discipline plus 8 years relevant experience

OR

• Master’s degree in a relevant scientific discipline plus 5 years relevant experience

OR

• PhD in a relevant scientific discipline plus 3 years relevant experience is required.
• Must be able to manage and actively drive multiple investigations and projects at varying stages of completion to meet respective due dates.
• Demonstrates and influences understanding of GMPs, root cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make qu