Sr. Manager, Technical Regulatory Compliance
Job Location:
West Chester, OH - USA
Monthly Salary:
Posted on:
Vacancies:
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:
QualityJob Sub Function:
Quality & Compliance AuditJob Category:
ProfessionalAll Job Posting Locations:
Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America West Chester Pennsylvania United States of AmericaJob Description:
DePuy Synthes is recruiting for a Sr. Manager Technical Regulatory Compliancelocatedin West Chester PA or Palm Beach Gardens FL or Raynham MA.
Job Overview
The Sr. Manager Technical Regulatory Compliance provides senior leadership for regulatory compliance related to technical systems processes and documentation. This role ensures that technical and operational activitiescomply withapplicable regulatory requirements quality system standards and internal policies. The position plays a critical role in managing compliance risk supporting audit and inspection readiness and enabling compliant execution of complex technical initiatives by partnering closely with Quality Regulatory Affairs Engineering Manufacturing and IT teams.
Key Responsibilities
Lead and oversee technical regulatory compliance activities in alignment with global and regional compliance strategies.
Provide compliance oversight for technical processes computerized systems and documentation supporting regulated activities.
Interpret regulatory and technical standards and translate them into actionable compliance requirements and controls.
Partnerwith Quality Regulatory Affairs Engineering Manufacturing and IT teams to ensure compliant system implementation and change management.
Lead audit andinspectionreadiness related to technical compliance including internal audits and health authority inspections.
Monitor compliance risks trends and performance metrics and drive corrective and preventive actions.
Ensure consistent application of global and sitespecific compliance policies procedures and controls.
Drive continuous improvement initiatives to strengthen technicalcompliancegovernance efficiency and effectiveness.
Qualifications
Education:
Bachelors degree in Regulatory Affairs Quality Engineering Life Sciences Information Systems ora relateddiscipline (required).
Advanced degree in a scientific regulatory or technical field (preferred).
Experience and Skills:
:
Typically6-8years of progressive experience in Regulatory Compliance Quality Systems Engineering or related roles within a regulated industry.
Strong working knowledge of regulatory and technical requirementsimpactingquality systems and manufacturing processes.
Demonstrated experience leading audits inspections and regulatory assessments.
Proven ability to manage complex technical compliance topics across crossfunctional stakeholder groups.
Preferred:
Experience in medical devices healthcare or other highly regulated industries.
Familiarity with U.S. regulatory and technical compliance frameworks.
Experience working in a global or matrixed organization.
Exposure tocomputerized system validation (CSV) or data integrity programs.
Quality or Regulatory certifications (e.g. RAC ASQ).
Strong analytical riskmanagement and problemsolving skills.
Effective written and verbal communication skills with senior stakeholders.
Other:
Language: English.
Travel: Limited; occasional domestic travel.
Certifications: Quality or Regulatory certifications preferred but not.
For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.
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.
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 internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Agile Internal Audit Analytical Reasoning Audit and Compliance Trends Compliance Frameworks Compliance Management Compliance Policies Compliance Risk Critical Thinking Organizing Quality Auditing Quality Control (QC) Quality Standards Regulatory Compliance Risk Management Technical Credibility Third-Party AuditingRequired 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
