Principal Qa Information Systems Engineer (Remote Option)

The Position

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

This position is part of the Pharma Individualized Medicines Team responsible for the process development, manufacture and supply of personalized immunotherapies in collaboration with our global partners.

Position Summary:

Are you a Quality Assurance expert looking for an exciting opportunity to make a difference in the world of Cell and Gene Therapy? Roche is seeking a Principal Quality Assurance Information Systems Engineer to join our dynamic team of professionals. As a Core Team member, you will be responsible for providing quality oversight and expertise on the development, implementation, and maintenance of enterprise computer systems validation and computer software assurance for CGT technology applications.

As the subject matter expert for CGT Quality ERP and other CGT technical applications, including Orchestration and Exceptions Management System, you will be responsible for translating business needs into relevant process flows and drafting user stories and user requirements. You will also be responsible for ensuring compliance with current regulatory requirements and standards by developing and implementing a data integrity program.

In addition to your core responsibilities, you will provide project and validation support related to Quality Systems applications and ensure proper control mechanisms are in place to ensure the chain of custody and chain of identity for biospecimen/product from vein-to-vein. You will also contribute to Roche's strategy for cell and gene therapy industrialization, ensuring that our Quality Management System is up-to-date with emerging and changing regulations, guidance documents, and current industry best practices and expectations.

Minimum Position Qualifications:

• Experience in Cell & Gene Therapy and relevant quality experience is required
• Must have experience with either: a) Chain of Custody (COC) and Chain of Identity (COI) for biospecimen/final product from vein-to-vein OR b) ERP system upgrade and migration experience including IT validation support
• Bachelor’s degree

We are seeking a highly adaptable and skilled problem solver with a proactive "can-do" attitude, and be comfortable with uncertainty. You should have excellent influencing and negotiating skills to effectively engage with stakeholders across various levels of Roche's global operations, partners, and suppliers.

Location/Travel: The preferred location for this position is east coast/remote or Basel, Switzerland. Travel internationally may be required for this role.

Relocation has not been approved for this position.

For Colorado-based applicants, the expected salary range for this position is $150,120 - $175,140. For California and New York state-based applicants, the expected salary range for this position is $170,280 - $198,660 Actual pay will be determined based on experience, qualifications, 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 listed below.

Benefits

Roche offers highly competitive benefit plans and programs, including:

• Paid time off
• Medical, dental and vision insurance
• 401(k) and 401(k) matching
• Roche Long Term Incentive Plan (available at certain position levels)

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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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.