Senior Manager, Source Compliance

Johnson & Johnson

. Provide Worldwide Source Compliance leadership for programs associated with suppliers, including External Manufacturers and Direct & Indirect Suppliers .

Posted 11/10/2026full-timeUnited StatesSenior💰 $127,000 - $218,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Regulatory Compliance and Quality within the Medical Device or pharmaceutical sectors, with a strong focus on FDA regulations, ISO 13485 standards, and supplier management. Proven ability to lead compliance initiatives, manage supplier relationships, and engage with senior management effectively.

Highest-signal resume keywords

Regulatory ComplianceFDA RegulationsISO 13485 StandardsSupplier ManagementLeadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory ComplianceQuality ManagementSupplier AuditingCorrective Actions DevelopmentData AnalysisMetric ReportingProject ManagementInvestigations ExecutionCompliance Strategy DevelopmentHealth Authority Regulations

Soft Skills

Strong Communication SkillsLeadership SkillsNegotiation SkillsChange Management SkillsProblem Solving Skills

Certifications & Qualifications

Auditor Certification

Industry Keywords

Medical DevicesPharmaceutical ProductsExternal ManufacturersSupplier RelationsHealth, Safety and Environmental Guidelines

About the role

Key responsibilities & impact

Provide Worldwide Source Compliance leadership for programs associated with suppliers, including External Manufacturers and Direct & Indirect Suppliers
Ensure post-audit activities are executed, including Supplier Audit Response support and alignment, supplier action plan follow-up and closure, External Manufacturer follow-ups, metric reporting, and Source Compliance process improvement
Establish, manage, maintain and continuously improve Source Regulatory Compliance activities for assigned suppliers
Work with suppliers on Supplier Audit Responses and second-pass responses
Track supplier audit observations to completion
Execute External Manufacturer follow-ups
Analyze data and report compliance metrics
Work with suppliers and internal observation owners to achieve green supplier audit metrics
Prepare Source Compliance slides
Partner with ERC auditors, SPOCs, Quality and Supplier Relations to maintain robust supplier relationships
Establish and execute compliance strategies for supplier management
Recruit, develop and manage direct reports and contractors
Support external audits and inspections at sites and suppliers
Lead Source Compliance input to Executive Management review
Support development and review of external Health Authority and notified body responses related to supplier/purchasing control observations
Provide data, analytics and global health authority trend information to business partners
Develop proactive approaches to address regulatory trends
Provide oversight and compliance review of supplier remediation programs
Lead or contribute to strategic Source Regulatory Compliance initiatives and projects
Provide visibility on new supplier-related Health Authority regulations and inspection expectations
Establish and manage the assigned Source Compliance budget
Communicate business-related issues or opportunities to the next management level
Ensure compliance with Health, Safety and Environmental guidelines and applicable regulations
Perform other duties as assigned

Requirements

What you’ll need

A Bachelor’s degree in Business, the sciences or Engineering is required
A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is required
Strong knowledge of FDA & Global Medical device regulations and medical device standards such as ISO 13485 is required
Knowledge and experience in executing investigations and developing Corrective actions is required
Experience in managing professional associates is required
Experience working with suppliers is required
Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector is required
Demonstrated ability to work remotely and partner globally is required
Ability to foster an effective multi-functional, cross region, cross company team environment is required
Strong communication (written and verbal) skills are required
Strong leadership, partnering, influence, negotiation and change management skills are required
People leadership, project management, problem solving, investigation and presentation skills are required
Master’s Degree or other Advanced Degree preferred
Medical Device experience preferred
Experience in actively participating in external inspections preferred
Auditing experience, especially supplier auditing, preferred
Auditor certification preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year