Principal Specialist, Quality Assurance, Fremont CA

The Principal Specialist, Quality Assurance supports the leadership of key QA functions by acting as a subject matter expert in assigned areas and ensuring the adequacy, effectiveness, and continuous improvement of owned systems and quality activities. This role executes complex quality responsibilities to ensure alignment with product requirements, cGMP expectations, regulatory standards, internal quality policies, and agreed‑upon customer commitments. Through expert judgment and oversight, the Principal Specialist ensures that systems and processes remain robust, compliant, and inspection‑ready.

The Principal Specialist also leads, supports, and contributes to complex or major cross‑functional continuous improvement initiatives. By driving quality excellence across functions, this role strengthens product quality, enhances operational reliability, and ensures a high level of regulatory readiness. The Principal Specialist actively champions quality culture, influences decision‑making, and steers strategic improvements that directly support the reliable delivery of high‑quality products.

• Execute assigned tasks (e.g., authoring, performing, reviewing) in accordance with GxP procedures and Boehringer Ingelheim (BI) compliance requirements to ensure audit readiness.
• When assigned, interface with external stakeholders (e.g., CMB clients, CMOs, CLOs, suppliers) to:
  • Build trust, establish partnerships, defend the BI Quality System, and negotiate solutions supporting patient safety, regulatory compliance, BI Quality Systems, and established QAAs.
  • Act as the quality responsible person, first escalation point, and provider of quality guidance to resolve issues.
  • Establish, maintain, and sign Quality Agreements in accordance with BI SOPs and signature policies.
• Deliver deviation and change control responsibilities, including owning records and ensuring timely training completion.
• Prepare and review SOPs, work instructions, protocols (e.g., investigational, validation), templates (e.g., batch assessment checklists), plans (e.g., Annual Product Review plans), and Quality Agreements.
• Serve as delegated responsible person for product release, when assigned.
• Own or support implementation of the Batch Disposition quality system; oversee documentation readiness and batch record quality; act as deputy for site disposition governance.
• Allow, endorse strategy for, or approve activities (e.g., change records), assessments (e.g., trending reports), documents (e.g., specifications, protocols, qualification reports), and procedural updates (e.g., new SOPs) in alignment with BI governance and GxP regulations.
• Approve or review key GMP records, including master batch records, executed batch records, change controls, investigations, discrepancy risk assessments, complaints, annual product reviews, supplier qualifications, and extension requests.
• Maintain shopfloor presence during GMP operations to ensure compliance with SOPs, data integrity practices, cleanroom behaviors, and identification of operational risks, including for outsourced activities.
• Suspend GxP operations when warranted; provide remediation direction; resolve critical issues and escalate based on severity.
• Perform data collection, assessment, trending, evaluation, and reporting per area SOPs, including annual/periodic quality reviews, failure trending, and KPI preparation.
• Serve as subject matter expert (SME) and local management system owner; remain trained and knowledgeable on applicable local and global procedures.
• As system owner, design, establish, maintain, and implement global systems; develop KPIs; improve processes; identify, evaluate, and mitigate risks; and benchmark performance across BI sites.
• Perform necessary trend analyses and escalations; introduce system corrections and improvements; provide periodic status updates to site review forums, including senior leadership.
• Drive BI Fremont integration into global platforms; represent site needs in global forums; influence global and divisional MSOs to establish practical, implementable procedures.
• Ensure active engagement in identifying, sharing, and adopting best practices across BI sites; support continuous improvement systems and processes.
• Partner with Manufacturing to identify process gaps, provide on‑the‑spot coaching, and drive compliance and quality culture improvements.
• Perform additional quality responsibilities, including preparing regulatory submission documentation, supporting audit readiness, assisting during inspections, and representing BI Fremont by defending site practices and decisions.

Communications

• Written: Produces approver‑level records and clear disposition or approval rationales.
• Verbal: Leads discussions to decisions under tension; frames risk and impact sharply for stakeholders.
• Digital: Standardizes decision‑support visuals (e.g., Pareto charts, trend analyses where applicable) and coaches others on effective data storytelling.

Leadership & Stakeholder Management

• Leads difficult conversations to alignment and manages supplier or client quality topics as assigned.
• Shapes team ways of working and coaches across teams to elevate performance.
• Leads cross‑functional continuous improvement initiatives with measurable outcomes.

Technical & Operational Excellence

• Owns significant portions of the Quality Management System; identifies systemic risks; leads audit and inspection defense for the area.
• Partners on validation strategy, de‑risks technology transfers, and reinforces robust operational controls.
• Anticipates failure modes (e.g., via FMEA) and ensures trend and report evaluations drive durable CAPAs and governance inputs.