Compliance Officer jobs

About the role:

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

• Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
• Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.

• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Act as the sub-process steward for the global Internal Audit process.
• Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.

• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.

• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross-functional quality initiatives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field
• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
• Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Ability to travel up to 25 - 30% domestically and internationally

Preferred qualifications:

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Responsibilities

• The successful candidate will work with GPS engagement teams, supporting functions, and EY’s Client Technology and Global Information Security organizations to develop and maintain a security and compliance program across all environments, platforms and applications used or desired for use by GPS. Responsibilities include:
• Strategy, Governance and Risk Management
• Development and execution of a multi‑year cybersecurity strategy and investment roadmap aligned to business objectives and federal contract requirements.
• Development, management and maintenance of the GPS IT security risk management policy and/or procedural documentation mapped to NIST SP 800-37 (RMF), NIST SP 800‑53, NIST SP 800‑171, NIST SP 800‑161 (C‑SCRM), and NIST SP 800‑218 (SSDF)
• Ownership of the enterprise risk assessment (ERA), business impact analysis (BIA), and security metrics; present posture and material risk to the COO on a recurring cadence.

Defense Industrial Base Compliance (Classified & Unclassified)

• Manage GPS compliance with DFARS 252.204-7012, 252.204-7020, and 252.204-7021. This includes:
  • Leading DFARS/CMMC readiness and ongoing compliance.
  • Serving as the Affirming Official (AO) and maintaining an accurate SPRS self‑assessment score with defensible Plans of Action and Milestones (POAMs).
  • Achieving and maintaining CMMC certification at level 2.
  • Overseeing management and maintenance of POAMs.
• Ensure systems operated for the government are designed properly and assessed against the appropriate requirements such as FedRAMP, Cloud Computing Security Requirements Guide, IRS 1075, and MARS-E.
• Ensure safeguarding and incident reporting obligations for CUI (e.g., DFARS 252.204‑7012 72‑hour reporting) are met; coordinate with DC3/DIBNet and affected customers when necessary.
• Oversee NISPOM compliance for classified systems; partner with FSO to achieve and maintain Authorizations to Operate (ATOs).
• Ensure proper handling of export‑controlled data (ITAR/EAR).
• Prepare for and lead Program through contractually required assessments and customer audits; keep evidence, policies, configurations, and logs audit‑ready.
• Respond to government inspections or audits in coordination with EY Information Security and Risk Management.

Secure Cloud, Identity & Enterprise Platforms

• Own security architecture and controls for Azure Government (Azure Gov) and Microsoft 365 GCC High tenants, including Conditional Access, PIM/PAM, encryption, logging/retention, and data governance for CUI.
• Implement Zero Trust principles across identity, endpoints, networks, and workloads; drive continuous verification and least‑privilege.
• Deploy and operate EDR/XDR, SIEM/SOAR, DLP, CASB/SSE/SASE, MDM, key management/HSM, and vulnerability/configuration management at scale.
• Oversee user authorization process and ongoing attestation of user authorization and access.
• Assist to resolve GPS practitioners’ access or other issues with Enclave environments.
• Ongoing development, coordination and sustainment of Information Security Continuous Monitoring (ISCM) Program across all applications within the environment.

DevSecOps & Secure SDLC

• Establish a software security program aligned to NIST SSDF (SP 800‑218) and EO 14028 expectations; integrate security into SDLC across GitHub and Azure DevOps.
• Govern AppSec tooling and policy: SAST (e.g., Checkmarx), DAST (e.g., Qualys/AppScan), SCA/OSS (e.g., Mend), IaC/container/K8s scanning, and Wiz/Wiz Code; enforce build‑time gates and remediation SLAs.
• Require SBOM generation, artifact signing/provenance (e.g., SLSA targets), and secrets management across all repositories and pipelines.

Detection, Response & Resilience

• Develop, manage and maintain GPS incident response program.
• Lead SOC and CSIRT functions: 24×7 monitoring, threat intelligence, purple/red‑team exercises, and executive tabletop drills.
• Maintain and test the Incident Response Plan and Cyber Crisis Playbook, including regulatory/customer communications and forensics preservation.

Effective Business Integration

• Ensure development of fit-for-purpose solutions that support the business activities.
• Manage integration of Firm applications into the GPS Enclave environment.
• Understand and facilitate communication of EY’s IT disaster recovery and business continuity plans to GPS clients, potential clients and engagement teams (including engagement team responsibilities).
• Augment existing Client Security Assurance reviews of data protection requirements contained in RFPs/RFQs to adequately respond, and assist in development of GPS client security and data protection (confidentiality) plans.
• Monitor regulatory or other developments in INFOSEC principles, regulatory requirements and leading practices.

Leadership, Team and Budget

• Role model a leadership style that brings infrastructure, application and cybersecurity professionals together to collaborate constructively on the design, implementation and operation of controls.
• Build and mentor a high‑performing organization spanning Policy/GRC, AppSec/DevSecOps, Security Engineering/Architecture, SOC/IR, and Third‑Party & Supply‑Chain Risk.
• Own the cybersecurity budget and vendor portfolio; rationalize tools and services for value, performance, and compliance.
• Participate in purchasing and enhancement of third-party tools for GPS.
• Augment and potentially streamline existing Vendor Supplier Risk Assurance Program during evaluation of subcontractor compliance with applicable cybersecurity and data protection clauses.
• Drive a security‑first culture: ongoing training, phishing simulations, secure coding education, and leadership engagement including data protection and awareness and role-based training programs.
• Coordinate and respond to annual (or more frequent) independent risk assessments and cyber security reviews.

Qualifications:

• 12+ years of progressive cybersecurity leadership, including 5+ years at the enterprise or business‑unit executive level.
• 5+ years FISMA related experience
• Bachelor’s degree in IT-related field or bachelor’s degree in non-IT related field with a total of 10 years of information security experience
• Master’s degree preferred
• Ability to obtain and maintain Top Secret clearance
• US citizenship required
• Clearance: The ability to obtain and maintain top secret required
• Thorough knowledge and understanding of:

• • FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems
  • DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting
  • NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations
  • NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations
  • GSAM 552.239-70, Information Technology Security Plan and Security Authorization, 552.239-71, Security Requirements for Unclassified Information Technology Resources and similar clauses in agency FAR supplements
  • FISMA
• Specialized knowledge and experience with the implementation of the NIST Special Publication (SP) 800 family of publications, particularly those associated with the Risk Management Framework
• Proven experience in the Defense Industrial Base with DFARS/CMMC and NIST SP 800‑171 implementation and audits (including POA&M and SPRS management).
• Experience with FEDRAMP compliance authorization and monitoring
• Deep expertise securing Azure Government and Microsoft 365 GCC High environments
• Experience working with other Government cloud communities, including AWS
• Experience working with classified environments, achieving/maintaining ATOs, overseeing classified systems under NISPOM and DoD RMF, and working understanding of SCIF operations
• Knowledge and experience with vulnerability scanning execution, assessment, and analysis
• Knowledge and experience of networks, including LAN and WAN
• Knowledge and experience with application security, database security, and network security
• Experience with evaluating system, network, or infrastructure security controls against requirements such as FISMA, FIPS, and NIST guidelines
• Hands‑on leadership of DevSecOps and software security programs covering GitHub/Azure DevOps/Jenkins with SAST/DAST/SCA, IaC/container security, SBOMs, and supply‑chain controls.
• Demonstrated analytical, problem-solving, organizational, interpersonal and communication skills required.
• The ability to collaborate effectively with diverse stakeholders, including client-facing, legal, finance and contracting teams, executives, engineers, customers and assessors on a wide variety of tasks, as needed.
• Ability to foster professionalism and demonstrate integrity and confidentiality in all actions.
• Ability to demonstrate flexibility when required, sense urgency, organize and prioritize work, and achieve against tight deadlines.
• The ability to interpret and communicate regulatory requirements related to cybersecurity and data protection.
• Possession of excellent written/verbal communications skills.
• Possession of excellent analytical skills, including strict attention to detail.
• Ability to assess and weigh current and evolving security threats in an operational environment
• Possession of Information Systems Security Professional certification (CISSP)
• Certifications such as CISSP, CISM, CCISO, CCSP, CRISC, CISA, PMP, and relevant GIAC credentials preferred