Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
Execute Quality, verification and validation activities supporting regulated software applications classified as medical devices and non-medical device software. Job includes defining systems scope and objectives based on both user needs and a good understanding of applicable business systems, SDLC, design control processes, industry requirements, as well as product support processes. Work closely with application development group, validation group, and end users to design and validate new systems or modify existing systems.
Execute the quality function for Baxalta as the manufacturer of software application medical devices (software devices) by ensuring quality and regulatory standards are met through the following responsibilities:
Essential Duties and Responsibilities
• Analyze business processes and review/write system documentation (design history file) including user requirements, risk assessments, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements.
• Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems.
• Understand and follow as appropriate design control, SDLC, quality validation processes and application processes. Quality support for executing the design and development process, including risk management, for software medical devices, 510k and other regulatory submission projects.
• Support day to day quality operations related to the Change Control process in Trackwise 8.
• Review and/or update design history file documentation, protocols, system testing, reports, etc. Review executed verification/validation testing or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements.
• Provides support to business functions and IT concerning quality issues and ensure conformance to established performance requirements and procedures.
• Quality support in executing the complaint/CAPA/MDR/FCA processes relating to software devices.
• Own key tasks, require moderate direction, and handle moderately complex problems.
• Stays current with federal, state, local and company-specific rules, regulations and practices.
• Develop, gather, and measure relevant metrics and present as part of Management Review.
• Identify ways to improve efficiency and effectiveness of processes as part of the Quality Management System (QMS) for software devices meeting changing business needs and regulatory / quality requirements.
Working knowledge of 21 CFR Parts 504, 803, 807, 820, 11, FDA Design Control Guidance, FDA General Principals of Software Validation, FDA Guidance Related to 510K Submissions and ISO 13485.
Knowledge and experience with design control process for medical devices, SDLC and V,V&T techniques required
Strong written and oral communication skills required, leadership, influencing and project management skills
Understanding of relational databases required.
Must be detailed oriented and be able to work in a team setting.
Effective organizational, technical and problem solving skills.
Bachelor degree in Computer Science or a related field and 5 plus years of medical device experience
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
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Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.