Compliance & Validation Manager

Job Summary:
The West Compliance and Validation Manager is responsible for ensuring that the Real
Estate and Workplace Services (REWS) group and related company operations comply
with industry standards and regulatory requirements.
The role oversees internal and external audits and manages compliance related risk. The
role will develop and validate company policies and operational processes. Additionally
the role will manage related vendors deliverables across multiple sites and regions.
The ideal candidate will have a strong understanding of compliance frameworks quality
assurance contract and vendor management and facilities regulatory standards within
Facilities and Construction focused Medical Device industry.
 

Key Responsibilities:
 

Compliance Oversight:
Monitor compliance with internal policies regulatory requirements and industry
best practices.
Develop maintain and enforce compliance programs and policies across REWS
operations.
Coordinate internal and external audits inspections and assessments.
Track findings and corrective actions to closure.
Ensure documentation is maintained and updated in accordance with regulatory
and company standards.
 

Validation & Quality Assurance:
Validate new facility systems workplace technology implementations and
processes to ensure quality compliance and performance.
Work with Construction partners to review and approve facility commissioning
HVAC systems cleanroom validations (if applicable) and systems validation & life
cycle.
Develop and manage documentation protocols including validation plans and
protocols (CC RAs IQ/OQ/PQ) deviation reports and final summary reports.
 

Vendor and Contractor Compliance:
Evaluate and monitor service providers contractors and partners to ensure
adherence to contractual obligations company standards and regulatory
requirements.
Perform compliance-relevant reviews during RFP/RFQ phases vendor
onboarding and operational performance.

Risk Management:
Identify compliance risks and proactively implement mitigation strategies.
Conduct root cause analysis and lead resolution planning for non-conformance
events.
Maintain a risk register for facility operations and real estate development
activities.
 

Training and Awareness:
Design and deliver compliance and validation training programs for internal
teams and external vendors.
Promote a culture of quality integrity safety and continuous improvement
throughout workplace operations.
 

Reporting & Communication:
Provide regular updates and reports to leadership regarding compliance status
audit outcomes and risk assessments.
Liaise with stakeholders (Quality Manufacturing Engineering Safety Security
and Resilience Legal Finance and IT departments) to ensure cross-functional
compliance alignment.

Qualifications :

Required Qualifications:
Bachelors degree in Engineering Quality Management or comparable work
experience.
58 years of experience in a compliance validation or quality assurance role
within Operations Quality Facilities or workplace services within Life Sciences
and Regulated Industries.
Strong knowledge of regulatory frameworks; QMS qualification validation ISO
standards (e.g. ISO ) FDA & EU regulations and local & regional
codes.
Experience with commissioning qualification & validation protocols (IQ/OQ/PQ)
medical cleanrooms and building management systems.
Excellent analytical organizational and communication skills.
Proven experience in managing third-party vendors and compliance audits

Preferred Qualifications:
Experience in highly regulated industries such as Biotech Medical Devices
manufacturing healthcare or finance.
Familiarity with computerized maintenance management systems (CMMS) and
integrated workplace management systems (IWMS).

Experience with Agile Neptune and Trackwise highly desired.
Masters degree or MBA is a plus.
Professional certifications (e.g. TEXT).
 

Work Environment:
Office-based up to 25% travel to regional and international sites.
May require presence on construction sites active facilities or industrial
locations.

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 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time