Staff Regulatory Compliance Specialist - 2406197151WDescriptionJohnson & Johnson is currently recruiting for a Staff Regulatory Compliance Specialist ! This position can be located in Cornelia or Athens Georgia.At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.Position Summary:The Staff 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 Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products RDC16/2013, Japan Ministry of Health, Labour 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.Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.Key Responsibilities:1. External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all time.a. Supports external audits and mock inspections: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.b. Executes site inspection readiness actions/toolsc. Participates in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).d. Assesses the risk and applicability of audit observations from other J&J facilities to determine impact to the site.e. Provides timely information to support the inspection process.2. Internal Audit Program and Management Executiona. Executes internal audits, as a team or lead auditor, against established internal audit procedures.b. Ensures adequate corrective actions for internal audits, including 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.c. Drives compliance and improvement in audit metrics.3. Enterprise / Sector Supporta. Connects and collaborates with other region’s compliance teams.b. Conducts audits at other sites as needed.4. Metrics Collection and Reportinga. Creates reports and communicates performance against metrics to key stakeholders.b. Highlights/communicates adverse trends in metrics, and take risk based action to remediate.5. Escalationsa. Escalates items in accordance with established procedures.6. External Standards and Regulationsa. Supports implementation of new external standards/regulations for the site.b. Maintains current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.7. Site Management Review and Quality Reviewsa. 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.b. Participates in reviews as required.8. Competency in all of the above plus the following:a. Capable of acting on behalf of the Compliance Manager.b. Accountability for results with proven track record.c. Demonstrated business insight to know how business works and knowledgeable in current and future business developments.d. Ability to take initiative in resolving business issues.e. Demonstrated influencing / partnering skills and be able to find common ground and solve problems.f. Demonstrated competency in project management skills with successful outcomes.QualificationsEducation:A minimum of a Bachelor’s degree or equivalent University degree is required with a minimum of 4 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is required with a focus in Engineering or related technical field preferred.Required:
Proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent communication and 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)
Knowledge of 21CFR 820, ISO 13485/EN 1SO 13485
Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
Ability to analyze complex data and integrate multi-disciplinary feedback.
Preferred:
Experience in Quality, Manufacturing or Engineering roles.
Experience leading internal quality system audits.
Experience leading or managing an internal audit program.
Advanced computer and database management skills
Statistical and analytical problem solving
ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282, ANVISA Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products RDC16/2013, Japan Ministry of Health, Labour and Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations.
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
Other:
This position may require up to 15% domestic travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Primary Location NA-US-Georgia-CorneliaOther Locations NA-US-Georgia-AthensOrganization Ethicon Inc. (6045)Travel Yes, 10 % of the TimeJob Function Enterprise ComplianceReq ID: 2406197151W
Full-time