is the first Platform-as-a-Service for manufacturing. We’re disrupting one of the largest industries in the world and empowering the people who make the things you interact with every day. Factories that are run with Tulip are more efficient, their workers are more productive, and they make fewer mistakes. Why? Because manufacturing apps guide and provide them with the right information at the right time. We call it bottom-up digital transformation. Join us if you want to help create the next industrial revolution.
You like to solve problems and build processes with a strong quality mindset. You are eager to figure out why things are broken and turn your learnings into improved processes. People tend to describe you as a hard worker, but you would say any job that’s worth doing is worth doing well, because you care. You are curious and excited to learn about new and old technologies powering a modern factory. You are a good communicator and able to speak GMP from engineers to c-suite. You are meticulously detailed. You are able to google your way out of most problems, and understand that every customer sees the world a bit differently.
About the Role
The Quality Manager is responsible for the implementation of Tulip’s QMS and leading all validation efforts on computerized systems (hardware & software) that have GxP impact, ensuring compliance with 21CFR11, GxP, GAMP, ISO9000, and ITAR requirements are established and maintained at all times. This includes prioritizing, executing, maintaining, and coordination of validation activities, evaluation of software applications against design specifications and user requirements. In addition may occasionally support software/application testing both internally and at customer sites.
What You'll Do:
- Implement and support Tulip’s QMS including computer system validation (CSV) strategy and lead validation efforts on computerized systems (hardware & software) that have ISO or GxP impact, ensuring compliance with US-21CFR part 11 requirements is established and maintained at all times.
- Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Validation Plan, Requirements Trace Matrix, Risk Assessment, Test Cases, Validation Summary Report, Change control, SOPs, etc.
- Provide guidance and/or support to other members of the Tulip team in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11/Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc.
- Coordinate training of validation project team members on testing and validation policies, practices and tools.
- Schedule and Conduct periodic internal QA audits
- Prepare and manage audits of Tulip by our customers
- 5+ years experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment.
- Requires a thorough knowledge and understanding of computer system validation processes and regulatory requirements, including GAMP5, 21 CFR part 11, Annex 11 and other harmonized international guidelines and GxP.
- Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits).
- Hands-on experience in validation of GxP systems is required.
- Experience in auditing of IT and validated systems are required.
- Strong analytical, problem-solving and conceptual skills.
- Excellent organizational skills; attention to detail.
- Ability to resolve system issues effectively and efficiently.
- Ability to prioritize workload and consistently meet deadlines.
- Practical understanding of project management principles and methodologies.
- Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable.
Working at Tulip:
We are building a strong, diverse team that values hard work, families, and personal wellbeing. Benefits of working with us include:
- Direct impact on product and culture
- Company equity
- Competitive benefits package including Health, Dental, Vision, HRA, Commuter, and 401k
- Flexible work schedule and unlimited vacation policy
- Fully stocked office kitchen with weekly meals and beer on tap
- Company outings and happy hours
- Fitness subsidies
- Dog-friendly office
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will transform manufacturing.