Lead Technology Compliance

Jobtailor; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

Jobtailor is seeking a senior Compliance professional to lead audits and ensure GxP regulatory alignment across technology and healthcare solutions. You will drive closed-loop audit programs, oversee software GxP controls, and interface with global regulatory agencies to shape guidance.

Responsibilities include planning audits, delivering corrective actions, and communicating complex regulatory requirements to executives, while partnering with Quality teams to close gaps and strengthen

Qualifications

• A Bachelor’s or equivalent University degree is required.
• 3+ years of progressive experience in Quality and Regulatory Compliance in an international context, in a regulated healthcare environment.
• Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
• Auditor experience in a regulated industry, preferably healthcare.
• Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
• Experience interfacing with global regulatory agencies (FDA, MHRA, TGA, etc.).
• Experience interpreting regulations and translating requirements into practical strategies.
• Ability to resolve complex regulatory compliance issues.
• Ability to analyze and interpret regulatory documents.
• Proven experience driving progress to strategic plans under ambiguity.
• Excellent written and oral communication, including clarity on complex topics.
• Ability to present information to executive management clearly.
• Ability to lead teams and build cross-functional relationships.
• Ability to influence, negotiate, and build credibility.
• Strong partnering to facilitate collaboration.
• Audit management and delivery.
• Analytical mindset

Responsibilities

• Execute closed loop Supplier Audit and GxP System Periodic Review Programs, including audits and corrective actions.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partner with Technology Quality and Business Quality to gap assess between current practices and regulatory expectations.
• Establish corrective actions with Quality partners to address identified gaps.
• Lead resolution of complex situations during audits.
• Maintain awareness of industry standards, trends and best practices in GxP technology.
• Provide compliance input and final review of responses to health authority observations.
• Support Technology Quality and sector Business Partners on GxP processes end-to-end.
• Proactively contribute to compliance program development from the outset.

Skills

Quality and Regulatory Compliance

Auditing

Regulatory Agency Interaction

Data Integrity

Cross-Functional Collaboration

Education

Bachelor’s degree or equivalent

Tools

GAMP5

21 CFR Part 11

Annex 11

SDLC Methodologies

Job description

• execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
• providing direct support to business segments during global health authority inspections and other third‑party audits related to Technology areas.
• compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
• assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
• reports to the Head, Med Tech & Emerging Compliance.
• Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow‑up status, escalating critical issues/risk to senior leadership.
• Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
• Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
• Works with Quality partners to establish corrective actions to address any identified gaps.
• Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
• Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
• Provide compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance.
• Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to‑end technology areas.
• Proactively sense for opportunities and actively participate in compliance program development from the outset.

Requirements

• A minimum of a Bachelor’s or equivalent University degree is required.
• 3+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
• Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
• Auditor experience in a regulated industry, preferably HealthCare Industry
• Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
• Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
• Experience interpreting regulations and translating regulatory requirements into practical strategies.
• Ability to resolve complex regulatory compliance issues.
• Ability to analyze and interpret regulatory documents.
• Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations.
• Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
• Ability to effectively present information to executive management.
• Ability to lead teams and build strong cross‑functional relationships.
• Ability to influence, negotiate, and build credibility.
• Strong skills in interdependent partnering to facilitate collaboration.
• Audit management and delivery
• Analytical mindset

Core Competencies

Demonstrates expert knowledge of Quality System Regulations, ISO, ICH, and cGMP regulations, with a strong focus on GxP compliance in technology and healthcare. Proven ability to lead audits, manage regulatory compliance issues, and effectively communicate complex regulatory requirements to stakeholders.

Highest-signal resume keywords

• Quality System Regulations
• GxP Compliance
• Regulatory Agency Interaction
• Audit Management
• Data Integrity Requirements

ATS Optimization Keywords

Hard Skills

• GxP System Periodic Review
• Audit Planning
• SDLC Methodologies
• GAMP5
• Regulatory Document Interpretation
• Compliance Metrics Analysis
• Corrective Action Planning
• Risk Communication
• Quality Compliance Management
• Healthcare Regulatory Compliance

Soft Skills

• Excellent Communication Skills
• Influencing and Negotiation
• Cross‑Functional Collaboration
• Analytical Mindset
• Problem Solving

Industry Keywords

• ISO
• ICH
• PIC/S
• CGMP
• FDA
• MHRA
• TGA
• Annex 11
• 21 CFR Part 11
• Part 210