Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to e nsuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life".
Position: Major Task
Computer System Quality Subject Matter Expert (SME) for life cycle of Computerized Systems (CS) with a focus on Laboratory Systems across Bayer Biotech. Provides oversight on new system implementations as well as maintenance of existing systems. This global role partners internally and externally to strategize best possible solutions that meet industry norms as well as regulatory expectations. Provides guidance to Business Analysts, Engineering, IT and other peer groups across sites to guide Quality by Design, validation strategies and standards, risk management strategies, and operational standards. Acts as a Quality Unit SME for CS during regulatory inspections. Ensures compliance to applicable regulations and relevant accepted industry guidance for computerized systems. Maintains regulatory knowledge and proactively assesses risk and mitigation factors. Establishes and maintains standards for all CS Life cycle phases and targets continuous improvement. Evaluates solutions and proactively influences the implementation of standardized and harmonized solutions across Biotech.
• Global Computer System Quality SME:
o Determine and establish compliance requirements for a wide range of computerized systems, with a focus on laboratory systems and equipment, related interfaces, consistent with Corporate Directives and regulatory expectations. Influences standard and simple solutions globally.
o Must understand complex relationship of manufacturing systems, controls and batch and process data, laboratory processes (end to end, including multivariate analysis of data across different systems). Work with COEs to define, influence and implement global standards. Review and approve system and process documentation and ensure compliance and maintain/ update all necessary Master Plans. Create, enhance, and improve global documents/standard.
o Completes projects in a timely manner and with high quality and accuracy.
o Apply a Risk Based approach to systems and processes. Ensures that validation efforts are appropriate based on assessed risk.
• The ability to identify issues of significance, communicate complex issues to peer groups and site as well as global leadership, provide multiple alternatives to the solution of complex problems and the ability to provide guidance in their implementation.
• Advises sites with regards to regulatory environment, changes, standards and processes. Ensures change management processes are followed. Partners with POs to assess the cumulative and cross-systems impact of process changes to maintain a state of compliance.
• Monitors and improves quality programs designed to oversee system compliance, in partnership with other quality leaders. Works very effectively with other groups at site, regional and global level. Continuous improvement based on industry trends and accepted guidance such as GAMP.
• Defines and Oversees systems and IT enabled processes, partnering with system owners and business process owners to enhance the state of compliance. Influences the implementation of appropriate and harmonized solutions. Ensures that cross functional processes enabled through multiple computerized systems are controlled and compliant.
• Provides effective leadership in training and developing customers/stakeholders. Leads and motivates members of the functional areas. Supports workforce diversity, quality and safety. Encourages and lives LIFE values as essential elements of Bayer culture.
• Networks internally and externally extensively to proactively remove process inefficiencies and streamline efforts. Assess GMP processes and identify opportunities to be more effective through implementation or improved utilization of current computerized systems (e.g SAP, LIMS, MES.). Drive improvements in engineering and IT lifecycle processes to improve efficiency while maintaining compliance.
• Supports regulatory inspections as SME. Evaluates the impact of cross-site inspections, participates in internal and/or vendor audits
Your qualifications Position: Skills
B.S. in Engineering, Computer Science, or related field - 10+ years of relevant experience in pharmaceuticals or a related industry with emphasis on SDLC and Lab Systems such as (LIMS, Empower, ELN, Instruments) and related interfaces and platforms. Comprehensive experience with design, deployment and operational strategies for LIMS. Experience with interfaced systems (e.g SAP, MES etc) highly preferred.
• Excellent working knowledge of GAMP and regulatory requirements including 21 CFR Part 11, Annex 11. PIC/s guidelines and other cGMPs.
• Excellent technical writing, project management and communication skills.
• Hands on experience in setting validation strategy, evaluating risks and issues, applying SDLC, and analyzing business process and system design in local and global platforms
• Proven expertise in application of electronic records and signatures, GAMP, global regulatory compliance and SDLC, with extensive experience in interfacing with regulatory bodies
• Strong technical understanding of Databases (Oracle), and Reporting Tools. Thorough understanding of LIMS, Chromatography software, lab systems a must.
• Effective technical/business communication skills and ability to interact and influence different levels of management, locally and globally. Proven ability to work with diverse environments and cultures globally.
• Strong experience in risk strategies, harmonized solutions and industry standards forbusiness processes.
• Excellent organizational skills, networking skills and influencing and collaborating skills.
• Be able to work independently with minimum supervision
• Multilingual (German, English, Mandarin, Spanish etc preferred)
• Can identify, plan and resolve very complex problems, independently with minimal supervision; can lead teams through peer and upwards influence to meet goals. Results oriented. Can define, set and implement strategies.
• Exhibits sound judgment by: evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach.
• Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes. Committed to make a difference for better, efficient and compliant processes globally.
• Takes ownership over own development and guides others
• Can use data and scientific expertise to influence upper management and guide them towards compliant science based solutions with the appropriate sense of urgency. Courage to stand up and voice independent opinion, as appropriate. Exhibits alignment and integrity with company and management direction.
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.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.