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Commercial Quality Management Systems Execution Director
Johnson & Johnson. Provide strategic leadership for QMS governance and execution across multiple QMS elements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality Management Systems (QMS) governance, risk management, and compliance within the healthcare industry, with a strong focus on process optimization and team leadership. Proven ability to drive strategic initiatives and foster a quality culture across diverse teams and stakeholders.
Highest-signal resume keywords
Quality Systems ManagementGxP ComplianceRegulatory KnowledgeProcess OptimizationPeople Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality EngineeringQuality AssuranceSupplier QualityRisk ManagementGMP KnowledgeFDA RegulationsISO 13485Project ManagementDigital EnablementAnalytics
Soft Skills
CommunicationCollaborationInfluencingTeam BuildingCoaching
Tools & Technologies
Microsoft Office
Industry Keywords
Healthcare IndustryPharmaceutical IndustryMedical Device IndustryQuality ComplianceQuality Culture
About the role
Key responsibilities & impact- Provide strategic leadership for QMS governance and execution across multiple QMS elements
- Oversee local process execution and represent Commercial Quality in relevant cross-functional forums
- Assess process and platform optimization projects for Commercial Quality impact and adoption
- Oversee GxP activities related to end-to-end labeling and Product Traceability and Labeling Controls
- Own and drive Commercial Quality QMS strategy and execution with local operating companies, regional teams, and cross-functional stakeholders
- Enable proactive, risk-based quality management, harmonized execution, and continuous improvement across the Commercial Quality network
- Build and sustain networks that strengthen process ownership and accountability at local operating companies
- Support timely identification and escalation of quality and compliance risks and enable effective mitigation
- Advance performance through standardization, digital and automation enablement, analytics, and communication of QMS insights to senior leaders
- Champion quality culture and connect business partners, quality groups, and governance forums
- Provide strategic leadership, coaching, and development to direct reports
- Attract, develop, and lead a high-performing, global, and diverse team delivering the four Commercial Quality QMS execution pillars
Requirements
What you’ll need- Bachelor of Science or equivalent degree is required
- A degree in Engineering, Science, or another relevant Technical or Quality discipline or Master's degree in Quality or Regulatory is preferred
- Minimum of 10 years of experience in a highly regulated industry, including 10 or more years of Quality Systems experience in the healthcare industry
- Minimum of 5 years of Quality Systems management experience in the healthcare industry
- Experience in the pharmaceutical or medical device industry
- People leadership experience and experience working with senior leaders or leadership teams
- Broad technical knowledge across Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory, and Quality Compliance
- Strong knowledge of current GMPs and FDA and international regulatory requirements, including knowledge of quality and risk management terminology
- Demonstrated knowledge of the business impact of compliance issues and risk management
- Demonstrated experience collaborating and influencing across global locations and preparing for and managing external third-party audits across multiple locations
- Exceptional written and verbal communication, project management, collaboration, influencing, team building, and development skills
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
- Strong compliance management record
- Demonstrated leadership ability and a record of delivering best-in-class Quality Systems results
- Expert knowledge of U.S. Quality System Regulations and ISO 13485
- Experience translating enterprise standards into efficient, risk-based, harmonized Commercial Quality processes and driving adoption across local operating companies
- Experience with process and platform optimization, standardization, digital enablement, analytics, and value realization
- Written and spoken English proficiency is required
- Candidates must already have authorization to work in the country of employment
- Immigration sponsorship and relocation support are not available
Benefits
Comp & perks- annual bonus with set target (% of pay) depending on pay grade / location
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- insurance plans for employees and, in some locations, eligible dependents
- sales commissions (where applicable)