Location:
Berkeley, CA
Posted Date:
4/5/2012
Position Type:
BS FULL TIME
Job Code:
0000026317
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
Bayer HealthCare is a leading global specialty pharmaceutical and biotechnology company, and the San Francisco Bay Area is home to more than 1,800 employees focused on the research, development and manufacture of biologics. At Bayer's Berkeley campus, employees ensure clinical manufacturing and process development of new protein therapeutics while also manufacturing Bayer's leading hemophilia product for patients worldwide. A second supply center is located in Emeryville where Bayer manufactures one of the first biologic therapies introduced for the treatment of multiple sclerosis and safely used by patients in more than 100 countries for nearly two decades. Discovering novel new medicines is the mission of Bayer scientists. Mission Bay is home to Bayer's new U.S. Innovation Center where scientists working in the fields of biologics and hematology research reach out and collaborate with academic institutions and small life science companies with the goal of improving patient care and patient outcomes.
Job description
The Quality SAP Business Lead is responsible for ensuring effective quality use of enterprise systems (SAP MES, LIMS, etc) through requirements gathering, detailed process analysis, system monitoring, troubleshooting, advanced training and project support. The Quality Principal Process Analyst collaborates with counterparts from other business functions (Global Supply Chain, Plant Maintenance/Engineering, Technical Operations and Global Biological Development) to support coordination between the Bayer IT service groups (BBS, BTS, BBTS), the Berkeley system users and stakeholders by using his/her operational skills and experience to assist with the maintaining functionality and compliance of the system.
Major Tasks:
1. Provide on-going business analysis, process excellence and project leadership skills training from Quality to business process analyst team members.
2. Identify and assess changing business requirements and their impact on Quality systems. Propose business process changes or SAP design changes (new or revised functionality) to support changing business requirements. Ensure changes or enhancements made meet 21 CFR Part 11 and validated requirements.
3. Use formal PMI methodology to establish project plans, deliverables and resourcing, and demonstrate proactive problem-solving and conflict resolution skills.
4. Identify and assess errors or issues raised by Quality and other stakeholders that may require SAP modifications. Perform root-cause analysis of identified issues. Propose business process changes or SAP design changes (new or revised functionality) to resolve the issue.
5. Provide leadership in establishment of Quality process management tools and competency. Train Quality process owners and stakeholders business process methods.
6. Support effective IT systems training for systems users. Work with Business Technical Training and SAP Security staff and management to support maintenance of systems training course content, catalog, security mapping and training delivery.
7. Respond to ad-hoc user requests for system troubleshooting, training or technical explanation. Provide support for systems enhancement, project or process improvement requests. Regularly attend functional staff meetings to present project and process improvement activity status and solicit feedback from users on enhancements, training and other means of driving more effective systems utilization and systems and process integration.
The Quality Analyst role drives efficiency, robustness and compliance in the business through continuous (IT-enabled) process improvement. Our substantial IT systems investment requires on-going maintenance, support and enhancements to continue to provide value to the business. Research indicates that systems deployment risk (compliance, project delays, cost overruns) is significantly mitigated through use of Quality analysts to ensure effective Quality user requirements, definitions and IT/business process integration.
Focus is internal. Leads cross-functional teams and provides expert guidance to more junior Associates. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions. Able to lead teams and promote team approach.
Requirements
Your qualifications
Bachelor’s degree in Computer Science, Business, Information Systems
or related field. Masters preferred.
- 8+ years of SAP ERP, MES, LIMS or relevant enterprise system experience
- 4+ years of business process analysis (data analysis, modeling, requirements definition, etc)
- 4+ years leading project teams
- Biopharmaceuticals, Biotech, Pharmaceuticals or Process industry experience
- Experience working in GMP/FDA regulated environment
- An equivalent combination of education and experience may be used to meet minimum requirements
- Knowledge of key business, (Order to Cash, Demand to Supply, Procure to Pay, etc)
Quality, and GMP processes and systems
- Understanding of 21 Part 11 regulations
- Strong project leadership experience
- Strong analytical mindset and ability to create consensus across multiple points of view
- Strong change management, communication and presentation skills
- Strong meeting facilitation skills
- Ability to quickly produce clearly-written, well-organized documentation
- Business Process Analysis training
- Business Process Management (BPM) training, certification preferred
- Project Management and Lean/Six Sigma training, certification preferred
Benefits
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now at:
https://mybayerjob.bayerbbs.com/sap(bD1lbiZjPTAwNSZwPTM0NDU3)/bc/bsp/sap/hrrcf_pinstappl/application.do?PARAM=UElOU1RfR1VJRD0yMEE2MzE0RURFQjcxQzI4RTEwMDAwMDAwQUJGRDkzMA%3d%3d&rcfcontext=APP_US
To all recruitment agencies: Bayer does not accept unsolicited third party resumes. www.myBayerjob.com
Bayer is an Equal Opportunity Employer
Reference Code: 0000026317
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