Principal Specialist, Quality Assurance, Fremont CA

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.

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…