Principal Specialist, Quality Assurance, Fremont CA

Boehringer Ingelheim; Fremont (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Boehringer Ingelheim Fremont is seeking a Principal Specialist, Quality Assurance to lead QA functions, ensure cGMP compliance, and drive continuous improvement across the site. The role emphasizes cross‑functional collaboration, investigations, change control, batch disposition, and regulatory readiness with oversight of the quality management system.

You will possess 7+ years in life sciences QA, a BS/BA, and preferably an advanced degree, mentoring teams, supporting audits, and partnering

Qualifications

• BS/BA in Life Sciences or Engineering is required
• Advanced degree is preferred
• Minimum of 7 years of experience in Quality functions within life sciences or related industry
• Minimum of 1 year of experience managing projects in a complex matrix organization

Responsibilities

• Execute QA tasks per GxP procedures and BI compliance to ensure audit readiness
• Interface with external stakeholders to support patient safety and regulatory compliance
• Lead deviation and change-control responsibilities and ensure timely training
• Prepare and review SOPs, work instructions, protocols, and Quality Agreements
• Serve as delegated responsible person for product release when assigned
• Oversee Batch Disposition quality system and site disposition governance
• Approve or review GMP records and regulatory submissions as needed
• Maintain shopfloor presence during GMP operations for data integrity and compliance
• Drive continuous improvement and KPI reporting across BI sites
• Partner with Manufacturing to drive quality culture and risk mitigation

Skills

Quality Assurance

GxP

Regulatory compliance

Leadership

Stakeholder management

Education

BS/BA in Life Sciences or Engineering

Advanced degree preferred

Tools

Quality Management System

Job description

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.

Description

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.

Duties & Responsibilities

• 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 elevate 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

Requirements

• BS/BA in Life Sciences/Engineering required
• Advanced degree preferred
• Minimum of 7 years of experience in Quality functions within the life sciences or a closely related industry.
• Minimum of 1 year of experience managing projects and priorities in a complex matrix organization.

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

Preferred

• Leads readiness and defense activities for client and regulatory audits within assigned scope
• Contributes to cross‑site alignment and benchmarking of Quality Assurance practices

Eligibility Requirements:

• 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 18 years of age or older

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long‑term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com