Commercial Quality Management Systems (CQMS) Execution Director

Johnson & Johnson•Titusville, NJ

4d•Hybrid

About The Position

The Director CQ QMS Execution provides strategic leadership for Commercial Quality QMS governance and execution, Product Traceability, and Labeling Controls. The role owns CQ QMS strategy and execution in partnership with Commercial Quality local operating companies, regional teams, and cross-functional stakeholders, enabling efficient, risk-based, harmonized execution of core QMS elements, proactive quality management, standardization, and continuous improvement.

Requirements

Bachelor of Science or equivalent degree is required.
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.
Written and spoken English proficiency is required.
Candidates must already have authorization to work in the country of employment.
Business Alignment
Compliance Management
Consulting
Continuous Improvement
Fact-Based Decision Making
ISO 9001
Performance Measurement
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Stakeholder Engagement
Standard Operating Procedure (SOP)
Tactical Planning
Technical Credibility

Nice To Haves

A degree in Engineering, Science, or another relevant Technical or Quality discipline or Master's degree in Quality or Regulatory is preferred.
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.

Responsibilities

Provide strategic leadership for QMS governance and execution across multiple QMS elements, including oversight of local process execution, Commercial Quality representation in relevant cross-functional forums, assessment of process and platform optimization projects for Commercial Quality impact and adoption, and 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, ensuring effective application of Commercial Quality System Elements.
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 meaningful communication of QMS insights to senior leaders.
Champion quality culture and serve as a conduit among business partners, quality groups, and governance forums, aligning stakeholder requirements and enabling adoption of QMS improvements.
Provide strategic leadership, coaching, and development to direct reports; attract, develop, and lead a high-performing, global, and diverse team that delivers the four Commercial Quality QMS execution pillars.

Benefits

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
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