Principal Quality Assurance Specialist

This position is part of Genentech’s Pharma Technical individualized and cell therapy team. In this role, you will be part of a team to help establish GMP-compliant processes for manufacturing, testing, and releasing products in a cutting-edge facility. 

As a Principal QA Specialist, you will be a part of a team committed to ensuring that our products meet specified requirements and legal compliance across customer markets.  You will collaborate with various departments to uphold Roche’s quality standards by reviewing and approving QA documentation, assessing internal controls, and facilitating compliance training.  Your efforts will help maintain high safety, quality, and regulatory standards, supporting the success of our innovative therapies.

The Opportunity:

In this critical role, you will ensure the quality and regulatory compliance of commercial and clinical products by overseeing their release and maintaining conformance with internal and external standards.  Additionally, you will:

• Perform lot disposition and release of products according to approved dossiers, adhering to compliance with local and international laws

• Provide Quality Assurance oversight throughout production operations, including Chain of Custody and Chain of Identity, ensuring GMP compliance

• Review and approve QA documentation, supporting continuous compliance and readiness for agency inspections

• Evaluate internal controls, conduct risk assessments, and manage documentation related to safety, quality, and regulatory standards

• Support and lead cross-functional Quality initiatives and projects, resolving Quality risks and deficiencies

• Manage deviations and CAPA processes, ensuring thorough investigations and timely resolution

• Participate in internal and external audits, serving as a Subject Matter Expert to defend lot disposition practices and batch records

Who You Are:

• You possess a Bachelor's Degree (preferably in Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant discipline) with at least 8 years of experience in Quality Assurance/Quality Control/Manufacturing within a GMP-regulated environment (or 6 years with an advanced degree)

• You possess expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry

• You possess demonstrated experience managing stakeholders and leading large, complex projects with multiple disciplines in a matrixed environment

• You possess expert knowledge of GMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations

• Strong understanding of quality systems, regulatory requirements, and compliance frameworks

• Excellent verbal and technical written communication skills, with the ability to distill complex issues into simple, comprehensible terms and demonstrated experience with communication to senior leaders

• Exceptional interpersonal, negotiation, and problem-solving skills, demonstrating tactical strategy and diplomacy

Preferred Experience:

• Experience with Individualized Medicine (ATMP), with early stage, commercialization and post launch processes for cell therapy to enable clinical use of products that may not meet approved specifications

• Experience with OOS investigations

• Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP) is highly desirable

The expected salary range for this position based on the primary location of Oregon is $114,700 (min) - $163,800 (mid) - $212,900 (max) of hiring range.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Notes:

• Relocation benefits are approved for this position.

• This position is an on-site role; remote options are not available.

• The ability to work flexibly outside of normal business hours may be required to support business operations.