The Position
This role is an integral part of our Individualized and Cell Therapy Quality team, dedicated to ensuring that our products and services meet the highest standards of quality and reliability.
With a focus on continuous improvement and adherence to regulatory requirements, our team plays a crucial role in safeguarding the excellence and safety of our offerings.
The Opportunity
As a Quality Assurance Senior Manager, you will play a key role in providing comprehensive quality oversight and guidance throughout the end to end manufacturing process of individualized and cell therapy products.
This includes overseeing starting materials, Drug Substance, Drug Product, and Finished Goods manufacturing, as well as analytics for in-process and release testing, and, when necessary, bio-specimen collection and shipment.
Your responsibilities will encompass ensuring compliance with regulations, contributing to the development of the quality strategy, and delivering innovative quality input and support to technical development teams.
Moreover, you will be tasked with overseeing clinical manufacturing operations at partner / CMO organizations and collaborating with cross-functional teams to ensure the successful manufacturing, release, and shipment of life-changing cell and gene therapies to patients.
Additionally, you will :
- Contribute to the development of quality strategy for product / platform development
- Represent QA in product and process development activities, including process transfer, validation, and design of new capabilities
- Provide Roche input and approval to partner / CDMO organizations on investigations, deviations, CAPAs, change control, and complaint investigations
- Negotiate, approve, and maintain quality agreements and ensure the requirements of the quality agreement are fulfilled
- Participate in quality review boards and run batch disposition activities in accordance with cGMP and Roche Policies
- Support and participate in compliance audits, Health Authority inspections, and interactions
- Provide timely support for Health Authority interactions and author / review responses to relevant Health Authority information requests
- Perform risk management, monitor Quality and compliance metrics, and review / approve relevant Quality documents for compliance to clinical trial protocol, regulatory filings and product specific requirements
Who You Are
- Possess a Bachelor's degree in life sciences AND a minimum of 7 years of relevant experience in the pharmaceutical industry
- Have at least 5 years of demonstrated experience in quality assurance operations
- Exhibit proficiency in interpreting cGMP regulations and showcasing quality oversight in pharmaceutical operations
- Demonstrate a proven track record of problem-solving, influencing stakeholders, and effectively managing complex situations in a matrix environment
- Comfortable with ambiguity and capable to think out of the box to challenge the status quo
- Exhibit excellent communication skills with a high level of intercultural awareness and the ability to work effectively in a global setting
Preferred Experience :
Cell and gene therapy product development / manufacturing
The expected salary range for this position based on the primary location of Oregon is $113,000 - $209,800. 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
Relocation benefits are approved for this posting.
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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