Commercial Quality Management Systems (CQMS) Execution Director

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Commercial Quality Management Systems (CQMS) Execution Director, located in either Horsham, Pennsylvania or Titusville, New Jersey.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose: 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.

You will be responsible for:

• 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.

Qualifications/Requirements:

• 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.

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.

Other:

• Written and spoken English proficiency is required.
• Key internal and external interfaces include Commercial Quality local operating companies and regional Quality teams; Innovative Medicine Quality & Compliance functions and Johnson & Johnson enterprise partners; Supply Chain; Regulatory Affairs; Safety; Medical Affairs; Commercial; process and platform owners; governance forums; Health Authorities; Notified Bodies; and international regulatory authorities.
• Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

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

 

 

The anticipated base pay range for this position is :

$150,000.00 - $258,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits