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Primary focus is quality oversight and management of design, development, verification and validation activities for GxP and non-GxP computer systems, and backup support for Blood Establishment Computer Software (BECS) classified as a medical device.
Defining systems scope and objectives based on both user needs and a good understanding of applicable business systems, SDLC methodology, design control processes, industry requirements, as well as product support processes.
Work closely with application development, validation and end users groups to design and validate new systems or modify existing systems.
Manage new plasma center startup tasks in the quality role related to review of installation/qualification/facility validation of medical devices and non-medical device computer systems.
No. of direct reports: 0
No. of indirect reports:Â 0
Analyze business processes and write system documentation 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.
Support documentation updates and performance of system verification and validation testing. Â Review validation or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements.
Understand and follow appropriate SDLC, quality validation processes and application processes. Provides support to business function and IT concerning quality issues and ensures conformance to established performance requirements and procedures.
Own key tasks, with little direction; handle complex problems and identify solutions or corrections.
Stays current with federal, state, local and company-specific rules, regulations and practices.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Support the change control, medical device complaint processes ensuring compliance to the 21 CFR Part 820 Quality System Regulation.
Follow and display the Takeda Values of Integrity, Fairness, Honesty, and Perseverance.
Exhibit behaviors to support the Takeda Global Core Competencies to Engage Others, Collaboration, Drive for Results, Strategic Approach, Lead Change, Self-Awareness and Develop Capabilities.
Be An Excellent Manager of Self and Others
Ability to drive decisions through Influence
Ability to manage, prioritize and deliver on core responsibilities
Decision-making and Autonomy
Support Management Review metrics, document control, inspection readiness, etc.
Review and approve documentation as part of software verification and system verification/validation to ensure it is complete, accurate and compliant with cGMP requirements.
Ability to work independently or in team environment, with cross-functional groups.
Ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.
Ability to mentor and act as information Quality Resource for lower level and other departmental team members.
Support design transfer activities for deployment of computer systems/software devices.
Open to new and innovative approaches for continuous improvement.
Initiating and embracing changes to processes as needed.
Confidence to challenge the status quo.
Participate in creating a "right first time" environment in everything we do through a focus on simplification, standard work, visual management and communication.
Ability to handle simple and complex problem solving.
Ability to thrive in a dynamic setting.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential:Â Bachelor's degree in Computer Science or a related field or 3 plus years of systems experience.
Desired:Â 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, Software Development Life Cycle (SDLC) and Verification/Validation techniques.
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.
Must have computer proficiency and able to utilize MS Office software (e.g., MS Word, MS PowerPoint, MS Excel) at an advanced level.
Internal Number: R0040433
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.