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Senior Specialist, Supplier Quality
Johnson & Johnson. Manage the supplier lifecycle for a portfolio, including selection, qualification, risk management, performance monitoring, issue management and compliance auditing .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Supplier Lifecycle Management, including Quality Management Systems (QMS) and compliance auditing, with a strong focus on Biotherapeutics and Advanced Therapies. Proven ability to lead projects, manage supplier relationships, and effectively communicate across various stakeholders.
Highest-signal resume keywords
Supplier Lifecycle ManagementQuality Management Systems (QMS)Regulatory ComplianceProject ManagementBiotherapeutics Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
E2E Supply Chain ManagementGMP KnowledgeNonconformance ManagementChange ControlSupplier InvestigationsAuditingRoot Cause AnalysisQuality System ManagementPerformance MonitoringRisk Management
Soft Skills
Effective CommunicationAnalytical SkillsSelf-MotivatedLeadershipInfluencing Skills
Certifications & Qualifications
Bachelor’s Degree
Industry Keywords
BiotherapeuticsSyntheticsAdvanced TherapiesInternational Conference on Harmonization (ICH)Regulatory Authorities Inspections
About the role
Key responsibilities & impact- Manage the supplier lifecycle for a portfolio, including selection, qualification, risk management, performance monitoring, issue management and compliance auditing
- Own supplier quality management system activities, including nonconformances, investigations, change control and audits
- Collaborate with site QA teams on supplier performance and supplier material or services changes
- Support local sites during customer, JJRC and health authority inspections
- Lead and maintain supplier relationships through business initiatives and compliance needs
- Scope supplier quality projects and lead project management to achieve goals and objectives
- Shape supplier management practices for advanced therapies, critical technology and software solution providers
- Serve as Supplier Quality Indirect Materials point of contact with site SPOCs
- Project-manage quality initiatives impacting the JJIM site network
- Deliver change management and communication updates within supplier quality
- Build effective networks and act as Supplier Quality point of contact for indirect supplier/services management
Requirements
What you’ll need- A minimum of a Bachelor’s Degree is required
- E2E supply chain management or site based QA, QC, QMS experience
- Knowledge of EQ/SQ QMS required to manage nonconformances, supplier investigations, change control and audits
- Minimum of 5 years’ in product / supplier lifecycle management across operating supply chain platforms including Biotherapeutics, Synthetics and Advanced Therapies
- Practical experience with GMP and International Conference on Harmonization (ICH) regulation
- Direct experience of regulatory authorities’ inspections
- Must be able to travel up to 10%-15% of the time
- Strong understanding of Biotherapeutics, Synthetics and Advanced Therapies marketed products, including raw material management, DP/DS manufacturing processes, related compliance and quality system management
- Effective verbal and written communication across internal/external stakeholders and leadership teams
- Excellent analytical skills to identify gaps and root causes and develop and communicate solution proposals
- Experience working remotely and independently, self-motivated and comfortable operating within tight deadlines
- Ability to lead and influence in a high matrix environment
- Project management, change management and communications mindset
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year
- 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
- Inclusive interview process and reasonable accommodations for applicants with disabilities