Johnson & Johnson announced plans to separate its Orthopaedics business to establish DePuy Synthes.
Following the transaction, the Director, Global Document Control – Quality Systems will be employed by DePuy Synthes.
Job Overview: The Director leads and governs the global document control function within Quality Systems, ensuring consistent, compliant management of quality documentation to support regulatory compliance, audit readiness, and operational excellence.
Key Responsibilities
Provide strategic leadership and oversight for global document control processes within Quality Systems.
Establish and maintain global document control standards, policies, and governance aligned with regulatory and quality requirements.
Ensure consistent execution of document lifecycle management, including creation, review, approval, distribution, and archival.
Drive harmonization and standardization of document control practices across regions and functions.
Partner with Regulatory Affairs, Manufacturing, Commercial Quality, and IT to support compliant documentation across the product lifecycle.
Support internal and external audits, inspections, and health authority interactions related to documentation and records management.
Monitor document control performance, metrics, and risks; drive continuous improvement initiatives.
Lead, mentor, and develop document control and quality systems teams, fostering a culture of compliance and operational excellence.
Qualifications
Education:
Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
Master’s degree or advanced technical degree (preferred).
Required experience and skills:
10–12 years of progressive experience in Quality Systems, Document Control, or related roles within a regulated industry.
Demonstrated leadership experience managing global or multi‑regional document control functions.
Deep understanding of quality system and regulatory requirements related to documentation and records management.
Proven ability to design and implement standardized, scalable document control processes.
Experience supporting audits, inspections, and regulatory assessments.
Preferred experience:
Experience in medical devices, healthcare, or other highly regulated industries.
Experience working in a global, matrixed organization.
Familiarity with electronic document management systems (eDMS).
Experience driving digital transformation or system modernization initiatives.
Quality or Regulatory certifications (e.g., ASQ, RAC).
Strong leadership, stakeholder management, and change‑management skills.
Other Requirements
Language: English required.
Travel: Moderate travel (domestic and occasional international).
Certifications: Quality or Regulatory certifications preferred but not required.
Base Pay
$150,000.00 to $258,750.00 per year.
Benefits
Medical, dental, vision, life insurance, disability, and legal insurance.
Consolidated retirement plan (pension) and 401(k) savings plan.
Long‑term incentive program participation.
Vacation – 120 hours per calendar year.
Sick time – 40 hours per calendar year.
Holiday pay – 13 days per calendar year.
Work, Personal and Family Time – up to 40 hours per calendar.
Parental leave – 480 hours within one year of birth/adoption/foster care of a child.
Condolence leave – 30 days for an immediate family member; 5 days for an extended family member.
Caregiver leave – 10 days.
Volunteer leave – 4 days.
Military Spouse Time‑Off – 80 hours.
Equal Opportunity Employer
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.
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