Manager, License, Data, & Quality (LDQ)
West Chester, OH - USA
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
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:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America Warsaw Indiana United States of America West Chester Pennsylvania United States of AmericaJob Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.DePuy Synthes is recruiting for a Manager License Data & Quality (LDQ) located in Raynham Massachusetts. West Chester PA Warsaw IN Palm Beach Gardens FL or NJ.
Job Overview
The Manager License Data & Quality (LDQ) is responsible for leading regulatory license management data governance and qualityrelated activities to support compliant product lifecycle management. This role ensures the accuracy integrity and availability of regulatory data and licenses while strengthening quality and compliance frameworks. The position plays a key role in enabling regulatory readiness audit support and effective decisionmaking by partnering closely with Regulatory Affairs Quality IT and business stakeholders across the organization.
Key Responsibilities
- Lead and manage regulatory license data and quality (LDQ) activities to ensure compliance with applicable regulations and internal standards.
- Oversee regulatory license management processes including tracking maintenance and renewals.
- Ensure accuracy completeness and integrity of regulatory data across systems and repositories.
- Partner with Regulatory Affairs Quality IT and business teams to align data and quality requirements with regulatory needs.
- Support regulatory inspections audits and internal assessments related to licenses data and quality records.
- Monitor changes in regulatory and data governance requirements and assess impacts to processes and systems.
- Develop and maintain procedures guidance and training related to LDQ processes.
- Drive continuous improvement initiatives to enhance regulatory data quality compliance and operational efficiency.
Qualifications
Education:
- Bachelors degree in Regulatory Affairs Life Sciences Information Management Quality or a related discipline (required).
- Advanced degree or professional certification in Regulatory Affairs Quality or Data Management (preferred).
- Experience and Skills:
Required:
- Typically 6-8 years of progressive experience in regulatory operations license management data governance or quality compliance within a regulated industry.
- Experience managing regulatory licenses records or registrations across product lifecycles.
- Strong understanding of regulatory data and quality requirements.
- Ability to interpret regulatory requirements and translate them into operational processes.
- Strong attention to detail and ability to manage complex data sets and documentation.
Preferred:
- Experience in medical devices healthcare or other highly regulated industries.
- Familiarity with regulatory information management (RIM) systems.
- Experience supporting regulatory audits or inspections.
- Experience working in a global or matrixed organization.
- Demonstrated experience driving regulatory data or quality process improvements.
- Effective stakeholder management communication and collaboration skills.
Other:
- Language: English required.
- Travel: Limited; occasional domestic or international travel.
- Certifications: RAC or relevant quality/data certifications preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .
Required Skills:
Preferred Skills:
Analytical Reasoning Business Writing Coaching Compliance Risk Fact-Based Decision Making Industry Analysis Legal Support Process Improvements Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Strategic Thinking Technical CredibilityThe anticipated base pay range for this position is :
$117000.00 - $201250.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Companys 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: - Experience:
Manager
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more