Primary Function of Position:
The Sr. Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams to transition from CSV to CSA framework.
Roles & Responsibilities:
- Develop strategies for continuous improvement aligned with Intuitive Surgical standards, customer needs, and regulations. Carry out hands-on execution of these programs effectively.
- Provide oversight for Validation/Quality process. - Manage and ensure effectiveness of GxP-related systems. - Support Intuitive Surgical improvement projects.
- 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.
- Advocating for product and process quality. Helps teams meet compliance standards. Does so with practicality and patience.
- Drive continuous education & awareness of company policies.
- Ability to motivate, manage performance, and mentor direct reports effectively.
Skills, Experience, Education, & Training:
- Minimum B.S. in Information Systems or related degree
- A minimum 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) highly preferred.
- Exceptional analytic and organization skills
- Proven written and oral communication skills
- Experience validating enterprise Information Systems - ERP, MES, and EDMS - is necessary for this position.
- 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 highly preferred
- Experience in CSV methodology for implementing and maintaining Infrastructure (IaaS), Platform (PaaS) and SaaS systems
- Proven working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) best practices
- Proven individual contributor with demonstrated ability to work autonomously
- Experience in developing\/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation highly 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 establish GXP relevance for automated systems
- Experience gathering/processing internal and external customer needs
- Strategic mindset with exceptional 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
#LI-Hybrid
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.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
