Principal Specialist, Quality Operations

$55,000 - $93,000/Yr

Boehringer Ingelheim International - Saint Joseph, MO

Full-time - Senior

Saint Joseph, MO

Merchant Wholesalers, Nondurable Goods

About the position

The Principal Specialist of Quality Operations at Boehringer Ingelheim Pharmaceuticals is responsible for providing real-time Quality Assurance support in Operations, ensuring compliance with USDA, EU regulatory requirements, and internal procedures. This role involves significant time spent in production, investigating major deviations that could impact product quality, and implementing corrective actions to prevent recurrence. The position emphasizes coaching and promoting a Quality Culture while contributing to the overall success of the company through collaboration and adherence to Good Manufacturing Practices (GMP).

Responsibilities

• Provides Quality Assurance support with 50% of time spent in Operations focused on compliance with USDA, EU regulatory requirements and BIAH procedures.
• 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.
• 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.

Requirements

• A Bachelor's degree in a relevant scientific discipline plus 8 years relevant experience OR a Master's degree in a relevant scientific discipline plus 5 years relevant experience OR a 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 quality decisions.
• Demonstrating advanced technical writing skills to provide complete, timely investigation reports.
• Demonstrating logical skills with excellence in written and verbal communication skills.
• Demonstrating advanced theoretical and practical knowledge of regulated processes and technical disciplines such as sterilization, aseptic processing, QC testing, quality and compliance, production excellence, and/or maintenance services.
• Able to select, develop, and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by BIAH.
• Demonstrating ability to lead and influence large projects and teams.
• Organizational skills, and ability to manage tasks based on experience leading projects.
• Ability to communicate clearly and professionally, both verbally and in writing.
• Well-developed interpersonal skills, with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
• Solid knowledge of Good Manufacturing Practice and international regulations.
• Ability to independently make sound decisions and manage priorities in alignment with department and site drivers.
• Ability to make and influence decisions with minimal supervision regarding the acceptability of product based on investigation provided.
• Previous experience in a leadership role preferred.
• Attention to detail and commitment to customer service.
• Technically self-sufficient and proficient in the performance of investigations including root cause analysis, impact assessment, CAPA development, and effectiveness of CAPA plans.
• Excellent attention to detail.
• Requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.

Nice-to-haves

• Previous experience in a leadership role preferred.

Benefits

• Competitive compensation and benefit programs
• Opportunities for collaboration internationally
• Support for a healthy working environment
• Diversity and inclusion initiatives
• Mobility and networking opportunities
• Work-life balance initiatives