South San Francisco, California
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The Position
Summary:In this position, you will report into the Global Annual Product Review (APQR) group, part of PTQ - Product Quality Management (PTQP). The successful candidate will be responsible for end-to-end (E2E) Annual Product Quality Review reporting for all (Small Molecule and Biologics) Roche commercial products. The APQR group receives approved site APQR reports from the entire Roche supply chain including CMOs, input from global and network functions, coordinates cross-site and end-to-end reviews, analyzes for trends and issues to assess the overall state of control for the manufacturing process and product quality. When necessary, appropriate actions are developed collaboratively, documented and initiated.
Job Responsibilities:
- Author end-to-en APQR reporting independently for products with complex supply chains
- Perform comprehensive assessment of product quality by analyzing/evaluating end-to-end APQR data to ensure state of control for manufacturing processes, specifications and control systems
- Collaborate and communicate with all site APQR business process managers (BPms), global/network functions and Product Quality Stewards to ensure timely and accurate APQRs are provided and analyses lead to appropriate conclusions
- Communicate identified issues in a timely manner and make recommendations for resolution. To facilitate issue resolution, ensure appropriate quality system elements are deployed and drive project/timeline completion
- Provide process training and guidance on APQR requirements to participating functions and their management
- Continuously improve APQR content/format and business processes to meet applicable regulatory requirements and evolving industry/compliance standards. Interpret applicable global regulations and help APQR management develop plans to ensure process compliance
- Identify and support improvements to information tools and systems, data analysis and trending practices to achieve higher efficiency and accuracy of the APQR data supply needs
- Support inspection readiness and presentation of the APQR process and report during regulatory agency inspections and partner/manufacturing collaborator and internal audits
- Perform other duties as assigned
Who You Are
Requirements:- B.A. or B.S. Life Sciences or related fields with = 8 years of applicable cGMP pharmaceutical or biotechnology experience required
- Excellent verbal and written communication skills and technical writing/editing skills including proficiency in MS Word, Excel, and PowerPoint. Experienced in generating and presenting complex data graphs and reports
- Demonstrated flexibility and persistent with a proficiency in decision-making and influencing skills along with a goal orientated approach to consistently deliver on time and on target
- Demonstrated expertise in analytical data analysis and critical thinking skills
- Knowledge and experience in analytical method and control systems including QC stability programs
- Experience or working knowledge of Statistical Process Control concepts and tools relevant to process and product monitoring (e.g., control charts, process capability analysis)
- Knowledge and experience in risk assessment as a quality management tool
Genentech is an Equal Opportunity Employer.
0 comments:
Post a Comment