Principal Specialist, Quality Assurance, Fremont CA

Boehringer Ingelheim • Fremont, CA

28d

About The Position

The Principal Specialist, Quality Assurance supports leadership of key QA functions as a subject matter expert in assigned areas, ensuring the adequacy, effectiveness, and continuous improvement of owned systems and quality activities. The role carries out complex quality responsibilities to align with product requirements, cGMP expectations, regulatory standards, internal quality policies, and customer commitments. It uses expert judgment and oversight to keep systems and processes robust, compliant, and inspection-ready.

The role leads, supports, and contributes to major cross-functional continuous improvement initiatives. It promotes quality excellence across functions, strengthens product quality and operational reliability, and supports regulatory readiness. The Principal Specialist champions quality culture, influences decisions, and directs strategic improvements that support reliable delivery of high-quality products.

The position also performs quality system ownership and oversight, including records and document review, batch disposition support, shopfloor compliance, trend analysis, audit and inspection readiness, and collaboration with internal and external stakeholders.

Requirements

• Bachelor of Science or Bachelor of Arts degree in Life Sciences or Engineering.
• At least 7 years of experience in Quality functions within life sciences or a closely related industry.
• At least 1 year of experience managing projects and priorities in a complex matrix organization.
• Produce approver-level written records and clear disposition or approval rationales.
• Lead verbal discussions toward decisions under tension and clearly frame risk and impact for stakeholders.
• Standardize decision-support visuals, such as Pareto charts and trend analyses where applicable, and coach others on effective data storytelling.
• 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 at least 18 years of age.

Nice To Haves

• Advanced degree.
• Lead readiness and defense activities for client and regulatory audits within assigned scope.
• Contribute to cross-site alignment and benchmarking of Quality Assurance practices.

Responsibilities

• Execute assigned authoring, performance, and review tasks in accordance with GxP procedures and Boehringer Ingelheim compliance requirements to ensure audit readiness.
• When assigned, interface with external stakeholders such as clients, contract manufacturing organizations, contract laboratory organizations, and suppliers to build partnerships, defend the BI Quality System, and negotiate solutions that support patient safety, compliance, and Quality Agreements.
• Act as the quality responsible person and first escalation point, providing quality guidance to resolve issues.
• Establish, maintain, and sign Quality Agreements in accordance with BI SOPs and signature policies.
• Perform deviation and change-control responsibilities, including owning records and ensuring timely training completion.
• Prepare and review SOPs, work instructions, protocols, templates, 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, and act as deputy for site disposition governance.
• Allow, endorse strategies for, or approve activities, assessments, documents, and procedural updates in alignment with BI governance and GxP regulations.
• Approve or review key GMP records, including master and 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, and cleanroom behaviors, and to identify operational risks, including for outsourced activities.
• Suspend GxP operations when warranted, direct remediation, resolve critical issues, and escalate according to severity.
• Collect, assess, trend, evaluate, and report data according to area SOPs, including annual or periodic quality reviews, failure trending, and KPI preparation.
• Serve as a subject matter expert and local management system owner, staying trained and knowledgeable about 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.
• Conduct trend analyses and escalations, introduce system corrections and improvements, and provide periodic updates to site review forums, including senior leadership.
• Drive BI Fremont integration into global platforms, represent site needs in global forums, and influence global and divisional MSOs to establish practical procedures.
• Identify, share, and adopt best practices across BI sites and support continuous improvement systems and processes.
• Partner with Manufacturing to identify process gaps, provide on-the-spot coaching, and improve compliance and quality culture.
• Prepare regulatory submission documentation, support audit readiness and inspections, and represent BI Fremont by defending site practices and decisions.
• Lead difficult stakeholder conversations to alignment and manage supplier or client quality topics as assigned.
• Shape team ways of working and coach across teams to elevate performance.
• Lead cross-functional continuous improvement initiatives with measurable outcomes.
• Own significant portions of the Quality Management System, identify systemic risks, and lead audit and inspection defense for the assigned area.
• Partner on validation strategy, de-risk technology transfers, and reinforce robust operational controls.
• Anticipate failure modes, including through FMEA, and ensure trend and report evaluations support durable CAPAs and governance inputs.

Benefits

• Competitive compensation and benefit programs.
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior