Sr. Manager, IT Computer System Assurance
Intuitive

Job Info

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Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

The Sr. Manager, IT Computer System Assurance (CSA) is responsible for providing leadership to transform quality and computer system validation programs to best in class using risk based approach. And expertise in developing and managing Information Technology GxP systems. The incumbent will have strong expertise, leadership and substantial experience    leading GMP related Validation activities in Pharma/bio technology/medical devices environment. This critical position  will be responsible for evaluating, and helping to ensure, GMP compliance in accordance with the regulations and guidelines, as well as the company's policies and procedures. The role will partner with Business and  Owners, and Quality teams to develop a strategy on how to transition from current CSV to  CSA framework  with strong risk based approach.
 

Roles & Responsibilities:

 

• Developing strategies and hands-on execution of continuous improvement programs that strongly align with Intuitive Surgical standards and customer and business needs while meeting all applicable Medical Device Regulations.
• Provide oversight for the overall management and effectiveness of  Validation/Quality process for GxP-relevant systems and products in addition to supporting other cross-functional Intuitive Surgical improvement initiatives.
• Manage a hybrid team of onshore / offshore resources, which include  high performing Validation Engineers and contractors.
• Compile and assess quality metrics to enable a data-driven framework and build the strategy for improving quality initiative.
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5.
• Solid knowledge of Medical Device standards such as 21 CFR 820, ISO 13485, ISO 14971.
• Define opportunities for their team and support resource prioritization.
• Support  team to produce high quality, consistent  documents that meet Intuitive Surgical's requirements.
• Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant.
• Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.
• Effectively identify and resolve complex system for compliance issues and appropriately communicates gating items to management and stakeholders.
• Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
• Participate and support the external audit programs related to GXP computerized systems.
• Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work.
• Authoring and/or revising SOPs, providing guidance on revising validation documents and protocols.
• Training and support of team, as well as training and support of larger team on compliance and quality concepts.
• A positive and approachable advocate of product and process quality. Enabling teams to meet expected compliance standards with practicality and patience.
• Drive continuous education & awareness of company policies.
• Ability to motivate, manage performance, and mentor direct reports effectively.

Qualifications

Skills, Experience, Education, & Training:

• Minimum B.S. in Information Systems or related degree
• 8+ year's relevant medical device / biopharmaceutical industry experience
• Additionally, 5-7 years of direct validation responsibilities in IT GxP Quality, Computer Systems Validation experience
• At least 4-5 years in a management or supervisory position
• Certification like CSQE ( Certified Software Quality Engineer) strongly preferred.
• Strong analytic and organization skills
• Strong written and oral communication skills
• Experience with validation of enterprise Information Systems, such as ERP (Enterprise Resource Planning), MES (Manufacturing Execution Systems), and EDMS (Electronic Document Management Systems) is required
• Thorough knowledge of quality management and CSV (GMP, 21 CFR Part 11, GAMP) aspects of computer system applications
• Knowledge of computer validation tool like Kneat or Valgenesis is strongly preferred
• Experience in CSV methodology for implementing and maintaining Infrastructure (IaaS), Platform (PaaS) and SaaS systems
• Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles
• Strong individual contributor with demonstrated ability to work independently
• Experience in developing/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation strongly preferred
• Experience identifying changes, driving improvements, and streamlining processes
• Good knowledge of global regulatory requirements related to both computer software validation and medical device design controls
• Experience in process validation, equipment validation, software validation, and/or computer software validation
• Knowledge of Quality System requirements to determine GXP relevance for automated systems
• Experience gathering/processing internal and external customer needs
• Strategic mindset with strong leadership and influencing skills
• Proven ability to develop and coach engineers at various experience levels
• Ability to manage multiple projects/deadlines with changing priorities
• Experience presenting to senior management & executive level audiences

 

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift : Day

Travel : 10% of the time

Travel Requirements:10% of the time Shift:Day

This job has expired.