Job Description

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

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description:

Johnson & Johnson is currently   recruiting for   a   Senior Regulatory Compliance Specialist ! This position can   be located in   Cornelia or Athens, Georgia.  

Position Summary:  

Under the supervision of the Regulatory Compliance Manager, the Senior Regulatory Compliance   Specialist   is responsible for   maintaining   a robust compliance program to ensure compliance with   all applicable regulatory requirements, company policies and procedures, and J&J Corporate   requirements .  

The Regulatory Compliance Specialist will lead and   maintain   the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements .   Leads and maintains assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282,   ANVISA RDC No. 665 (2022), Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products , Japan Ministry of Health,   Labor   and Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations, and any other regulations or standards applicable to the site. Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives   in accordance with   internal audit schedule.   Leads   inspection   readiness activities and actively participates in conduct of external quality system audits and inspections. Supports preparation of external audit and inspection responses .   Serves on cross site project teams consistent with company goals and   objectives   to improve overall compliance performance to   established   metrics and requirements.   Manages   assigned internal and external audit observations to ensure identified gaps are closed   in a timely manner .  

Conducts audits to good manufacturing practices, international organization for standardization and any other applicable   standard .  

Key Responsibilities:  

Coaches more junior colleagues in techniques, processes, and responsibilities.​ 

Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.  

Summary of Technical Duties:  

• Review of manufacturing processes,   instrument   and equipment   qualifications, ( IQ/OQ/PQ), design history   file , engineering documentation, etc.  

• Responsible for the data analysis and reporting for the sites and   identify   compliance issues  

• Lead,   participate   and/or support as needed in projects associated with audit process and application for the sites.  

• Lead/  participate   and/or support as needed in root cause investigations and quality systems and compliance improvements that results from Internal/External Audits, management   reviews   and any other NC/CAPA system indicators  

• Process Excellence projects such as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.  

• Complete statistical analysis of data for decision making.  

 

External   inspection   readiness and associated activities .   Support site audit readiness activities to ensure   inspection   readiness at all   time .  

• Supports external audits and mock inspections:   e.g.   Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site .  

• Executes site inspection readiness actions/tools  

• Participates in audit preparation activities (auditor   logistics , front room/ back room   arrangements, identifying/preparing SME’s, etc.).  

• Assesses the risk and applicability of audit observations from other J&J facilities to   determine   impact   to   the site.  

• Provides   timely   information to support the inspection process.  

 

Internal Audit Program and Management Execution  

• Executes internal audits, as a team or lead auditor, against established internal audit procedures, which can include but is not limited to audits of manufacturing processes, process/software validations, design controls, etc.  

• Ensures adequate corrective actions for internal audits, including robust root cause investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.  

• Drives compliance and improvement in audit metrics.  

Enterprise / Sector Support  

• Connects and collaborates with other region’s compliance teams .  

• Conducts   audits at other sites as needed.  

• Execute and/or supports Process Excellence projects as well as Lean Six Sigma of both new and existing processes, including but not limited to, quality improvements, cost reductions and productivity improvements.  

 

Metrics Collection and Reporting  

• Trend, analyze,   creates   reports and   communicates   performance against metrics to key stakeholders.  

• Highlights/communicates adverse trends in metrics, and take   risk based   action to remediate .  

 

Escalations  

• Escalates items   in accordance with   established procedures.  

 

External Standards and Regulations  

• Supports implementation of new external standards/regulations for the site.  

• Maintains current knowledge of regulatory changes through industry publications, seminars, professional   affiliations   and industry meetings.  

 

Site Management Review and Quality Reviews  

• Provides input (e.g.,   internal   and external audit results/status) into Site Management Reviews, Corrective Action Review   Boards   and Plant Quality Reviews to allow meaningful review.  

• Participates in reviews as   required .  

 

Other tasks  

• Establishes strong connection and collaboration with business partners at the   site, ( e.g.   Quality Operations, Training, Engineering and Manufacturing).  

• Where   appropriate ,   participate   on required site teams/projects  

• Plan, conduct and direct compliance projects requiring advanced knowledge of a  

specialized field.  

• Apply comprehensive and diverse knowledge of quality systems within broad assignment   areas.  

• May coordinate and direct activities of wage   employees;   responsible for their development   plans.  

• Interact with other sites to exchange support and resources aimed   to attain   common   compliance   objectives .  

• Make decisions and propose solutions to quality issues which could   preclude   a timely   or   effectiveness   implementation of compliance programs and initiatives.   

• Support execution   and management of activities related to external audit readiness, data trending, and the   internal audit program.  

• Provides compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.  

• Supports and promotes the safety and environmental   objectives   of the facility.   Comply with   all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).  

 

 

Qualifications:  

Education:  

A minimum of a   Bachelors   or equivalent University degree is   required , with a focus in Engineering or Technical field preferred.  

Required:  

• A minimum of 4 - 6 years of experience in   a   FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is   required .  

• Knowledge of 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282,   ANVISA RDC No. 665 (2022), Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products , Japan Ministry of Health,   Labour   and Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations.  

• Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs) .  

• Position requires proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent interpersonal skills.  

• Ability to work under   pressure   achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.  

• Ability to analyze complex data and integrate multi-disciplinary feedback.  

• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required .   Experience with Microsoft Project .  

• Excellent communication and interpersonal   relation   skills.  

Preferred:  

• Experience in Quality,   Manufacturing   or Engineering roles.  

• Experience leading internal quality system audits is preferred (Engineer and Senior Engineer level) and   required  (Staff Engineer level) .  

• Experience leading or managing an internal audit program.  

• Training in Process Excellence/Six Sigma tools and methodologies and Certification .  

• Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA )  and /or Lead Auditor certification .  

• Experience in leading and managing projects and milestones .  

• Experience with Minitab.  

• Advanced computer and database management skills.  

• Statistical and analytical problem solving.  

 

Other:  

• This position may require up to 15% domestic & international travel  

• This role is eligible for relocation funding  

 

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.  

 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People

Job Tags

Permanent employment, Work at office, Local area, Relocation,

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