Principal Quality Assurance Specialist

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 114,000 - 213,000; Full time

Job summary

An innovative firm is seeking a Principal QA Specialist to ensure the quality and regulatory compliance of commercial and clinical products. In this pivotal role, you will oversee the release of products, ensuring adherence to GMP standards and regulatory requirements. Collaborating with various departments, you will uphold quality assurance practices and lead cross-functional initiatives. This position offers the opportunity to work in a cutting-edge facility, contributing to the success of groundbreaking therapies while maintaining high safety and quality standards. If you are passionate about quality assurance and thrive in a dynamic environment, this role is for you.

Benefits

Relocation Benefits

Flexible Working Hours

Health Insurance

Retirement Plan

Employee Discounts

Qualifications

• 8+ years of experience in Quality Assurance within a GMP-regulated environment.
• Expert knowledge of GMP regulations and biopharmaceutical quality standards.

Responsibilities

• Oversee product release and ensure compliance with internal and external standards.
• Manage deviations and CAPA processes, ensuring timely resolution.

Skills

Quality Assurance Principles

Regulatory Compliance

Stakeholder Management

Problem-Solving Skills

Communication Skills

Education

Bachelor's Degree in Pharmacy or related field

Tools

EDMS

LIMS

SAP

Job description

The Position

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.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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