The Deviation Management Team (DMT) member acts as counsel and advocates for departmental compliance activities in alignment with our global and local standards and processes. In conjunction with Quality Control leadership, the DMT analyzes documentation, training, behavioral trends, work execution, and performance metrics relating to Quality and regulatory requirements. What you'll do as the Deviation Owner:You will manage the Quality Control deviation event assessments throughout the deviation... more details
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
The Opportunity:
The Deviation Management Team (DMT) member acts as counsel and advocates for departmental compliance activities in alignment with our global and local standards and processes. In conjunction with Quality Control leadership, the DMT analyzes documentation, training, behavioral trends, work execution, and performance metrics relating to Quality and regulatory requirements.
What you'll do as the Deviation Owner:
You will manage the Quality Control deviation event assessments throughout the deviation investigations in the Quality Management System.
- Manage each stage of the deviation investigation in alignment with due dates to ensure timely completion.
- Perform Reoccurring Deviation Assessments (RDA).
- Perform Causal Analysis (Schedule/lead RCA activities, as needed)
Help to set the scope of the deviation and escalate issues impacting quality, efficacy, and/or supply as appropriate to ensure resolution.
As the Change Management agent, you will Initiate, assess, and manage the lifecycle of QC change records in the Quality Management System.
Collaborate with QC change requestor to coordinate initiation, planning, impact, strategy, timelines, and deliverables of computer system, lab equipment, and document changes.
Who you are:
- Education: B.S./B.A degree +3 years experience, or Masters's Degree +1 year experience
- Experience is in pharmaceutical or biopharmaceutical industry.
- You have a sound experience in a cGMP and FDA regulations.
- Bring your Quality Management Systems experience to work.
The expected salary range for this position based on the primary location of Vacaville, CA is 85,000-145,000 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
NOTE: The Roche site at Vacaville is in an agreement to divest. This position could be transferred to the acquiring company.
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.
