“Johnson & Johnson companies are equal opportunityemployers” The Global Job Postingpolicy promotes the commitment to the advancement and development of ouremployees. We invite you to read this posting and apply if you areinterested in the position and meet the requirements.
Ethicon Endo (Independencia) , a Johnson& Johnson company, is a trusted, world-wide leader in medical devicescompany who contributes to the advance surgery and improves lives everyday. We are qualified as one of the top best place to work. JoiningETHICON is more than joining a great company, it means being a part of a legacyof innovation, development and philanthropy. For more information,visitwww.ethicon.com
Searching the besttalent for:COMPLIANCE MANAGER
Under the supervision ofthe Senior Manager Regulatory Compliance (Regional Compliance Manager), theCompliance Manager is responsible for establishing and maintaining a robustcompliance program to ensure compliance with all applicable regulatoryrequirements, company policies and procedures, and J&J Corporaterequirements.
ExternalAudit Readiness and Management
1.Lead and manage external audit readiness activitiesto ensure site readiness at all times including audit logistics, frontroom/back room arrangements, identifying/preparing SME’s, etc.
2.Partner with site leadership to host external auditsof the site e.g. Notified Body, Health Authority, Ministry of Health, FDA,Regulatory Agency, or JJRC/ERC.
3.Assess the risk and applicability of external auditobservations from other J&J facilities to determine impact to the site.
4.Schedule and manage mock audits/inspections as partof the External Audit Readiness activities.
5.Provide timely information to support the externalaudit/inspection process, including those that maybe taking place at othersites / locations.
6.Ensure external audit results arereported to management having responsibility for the matters audited. Providedaily communications regarding potential non-conformities or observations.
7.Provide guidance to prepare responses to anyregulatory agency notification or correspondence associated with the site.
8.Take the lead and provide guidance to ensure timelyand adequate responses to external audit observations related to the site,including failure investigations, root cause analysis, risk assessments,correction, corrective and preventive action plans, monitor and drive on-timecompletion of all action plans, perform follow-up with owners, and performeffectiveness monitoring and closure.
9.Ensure timely and accurate reporting and publishingof internal audit metrics. Drive compliance and improvements in metricstargets.
InternalAudit Program Management
1.Establish and manage an effective internal auditschedule for the site.
2.Ensure the resources needed to execute the internalaudit schedule are provided.
3.Ensure internal audits are executed according to theestablished internal audit procedures. Ensure independence between the internalauditors and the activities being audited.
4.Provide guidance on the interpretation of theregulatory requirements.
5.Provide management oversight and direction to theinternal auditors for the execution of the audit process.
6.Ensure internal audit results are reported tomanagement having responsibility for the matters audited.
7.Ensure timely and adequate responses to internalaudit observations, including failure investigations, root cause analysis, riskassessments, correction, corrective and preventive action plans, monitor anddrive on-time completion of all action plans, perform follow-up with owners,and perform effectiveness monitoring and closure
8.Ensure timely and accurate reporting and publishingof internal audit metrics. Drive compliance and improvements in metricstargets.
9.Ensure documentation and records related to theinternal audit program are maintained.
10. Ensureall quality system elements/processes applicable to the site are audited andappropriate actions are taken to meet the business and regulatory requirements.
Execute/coordinate program(s) for qualification andtraining of internal auditors. Assess qualification of internal auditors on aperiodic basis. Note: Programs caninclude franchise, supply chain, sector, and/or enterprise elements.
ExternalRegulations and Standards
1.Proactively assess and influence the externalenvironment by participating on industry and regulatory body work teams. As appropriate collect and provide siteinput. Communicate outcomes and trends to key stakeholders.
2.Support implementation of new/revised regulationsand standards for the site.
3.Maintain current knowledge of regulatory changesthrough industry publications, seminars, professional affiliations and industrymeetings
EDUCATION / DEGREE REQUIRED:
·A minimum of bachelor’s degree in technical area preferred
·Experience in External Audit readiness and management.
·Supervisory experience, preferably QA personnel.
·At least five (5) years of experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), including 2-3 years of specific experience in QA functions and a management/supervisory role.
KEY SKILL / KNOWLEDGE REQUIREMENTS:
1.Lead Auditor Certification, highly preferred.
2.Expertise on the FDA/ISO/Health Authority Quality System regulations and standards, with the ability to relate these to business/quality issues.
3.Ability to make decisions which will effectively support the business and company policies.
4 Required proven leadership, teamwork, initiative, and assertiveness skills.
5.Excellent written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
6.Ability to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
7.Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
8.Proven track record of demonstrating collaboration across the organization and at all levels.
9.Balanced technical understanding of products and processes combined with superior business and compliance acumen.
10.Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
11.Ability to recognize, build support for change and engage in constructive conflict.
12.High tolerance for ambiguity in a complex environment.
13.Ability to make the complex clear and easily understood by others.
14.Ability to build partnerships both internally and externally.
15.Capacity to put the customer central to all thinking
16.Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures.
17.Bilingual (Spanish & English).
PC background required
•Availability to work after regular schedule and during weekends
•Availability to work for limited periods of time in controlled manufacturing environments (CME’s) which require certain preparation and gowning practices.
·Office and Manufacturing Floor
Global Leadership Profile Competencies;
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; acts when needed.
Organization:ETHICON ENDO INDEPENDENCIA
Mexico-Chihuahua-Juarez-Durango 2751 Colonia Lote Bravo
E.E.S., S.A. de C.V. Mexico (8283)