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Senior CS / GCP Auditor

San Francisco, CA

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Genentech: Senior CS / GCP Auditor
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Senior CS / GCP Auditor
South San Francisco
California, United States of America
Job ID: 3601166542
The Position
We are looking for somebody who is familiar with the use of Computerized systems in clinical trials and safety reporting and who also has the ability to connect systems with process, can identify a GXP non-compliance but also determine impact and communicate that impact to our stakeholders who are Business Process Owners, System Owners, study teams etc.
Forming part of a highly successful auditing team, you can bring your expertise of GXP, Computer System Validation (CSV), Data Integrity and international regulations to the auditing processes associated with drug development. We believe in developing the capabilities of our team and invest in cross training across the GXP’s and CS.
As part of your responsibilities, you will participate and also lead audits of Investigator Sites, GXP & IT processes, Affiliates and Service Providers. You will, where required, assist with preparations for, and participate in, regulatory authority inspections. You will also partner with cross functional teams across the business to help develop a quality strategy that meet GXP compliance requirements.
Experience it for yourself. Everyday your contribution will positively influence patient outcomes.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You're searching for your next challenge in your pharmaceutical career, one where you are able to utilize your extensive experience of drug development processes and CSV regulations. You’re a strong influencer and can negotiate the most complex issues towards effective solutions.
To succeed in this role, you are able to display initiative, have a high attention to detail and you are focused on securing results with determination to solve problems. Your diplomacy and communication skills will also be needed in supporting the business and senior management within a cross functional, international environment.
Degree qualified in biomedical, scientific or IT discipline combined with strong industry experience within pharmaceutical or biotech clinical research, you ideally have CSV Quality Assurance auditing experience in an international environment. Experience in GVP or GCP Quality Assurance auditing would be preferable but not essential.
Must be willing to travel domestically and internationally on a frequent basis: 40% travel. CSV Auditing expertise.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the Apply online button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our .
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
Job Facts
Job Function
Quality Compliance & Audit
South San Francisco
California, United States of America
Full time
Job type
Additional Locations
Basel Headquarter
Basel-City, Switzerland
Shanghai - Field
Shanghai, China
United Kingdom - Field
United Kingdom
Hertfordshire, United Kingdom
Financial Services

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