Johnson & Johnson Careers
Senior Compliance Manager
Requisition ID: 5843180704
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Senior Compliance Manager located in Irving, TX.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster (BWI), Mentor, Neurovascular and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
The Senior Compliance Manager will have the objective of maintaining high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements for all Mentor sites. In addition, this position is responsible for the absence of significant quality issues and regulatory compliance actions by government agencies. External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all time.
• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections
• Audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.)
• Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
• Schedule and manage mock inspections as part of External Inspection Readiness activities
• Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations
• Provide daily inspection communications regarding potential non-conformities
• Prepare responses to any external inspection or other regulatory notification associated with site
• Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
Internal Audit Program and Management Execution
• Establish and execute an effective internal audit schedule for site
• Execute against established internal audit procedures
• Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
• Drive compliance and improvement in internal audit metrics
• Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements
• Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements
Enterprise / Sector Support
• Participate in JJRC audits as requested
• Where appropriate assure representation on all required business unit, sector, and/or enterprise teams (e.g., Do it Right)
• Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards
• Connect and collaborate with other compliance teams
Metrics Collection and Reporting
• Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain)
• Drive compliance to Quality and Compliance metric targets
• Create reports and communicate performance against metrics to key stakeholders
• Highlight/communicate adverse trends in metrics, and take risk based action to remediate
• Assure that required compliance-related events (e.g., field actions, inspections) are entered into EDGE per required timeframes
• Assure that EDGE information is current and updated in a timely manner.
• Escalate items in accordance with established procedures
• Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives
• Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business
External Standards and Regulations
• Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input. Communicate outcomes and trends to key stakeholders
• Support implementation of new external standards/regulations
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings
Site Management Review
• Provide input into Quality System Management Reviews (e.g., internal audits.) to allow meaningful review
• Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites. Ensure feedback and alignment with said changes
• Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, Manufacturing
• Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies
• As appropriate, perform annual performance appraisals for identified associates. Establish objectives and development plans for direct reports
• Support and promote the safety and environmental objectives of the facility
• A minimum of a Bachelor's degree is required, preferably in Engineering, Life Science, Physical Science or a related field.
• An advanced degree is preferred
• A minimum of eight (8) years of business experience is required
• A minimum of two (2) years of experience in a management/supervisory role is required
• Experience in the medical devices or pharmaceutical industry is preferred
• Experience with MHRA or other foreign regulatory agencies is preferred.
• Direct experience leading Notified Body/FDA audits is required.
• Strong knowledge of FDA and EU regulatory compliance is required
• Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485, ISO 14971, and other applicable international standards is required.
• Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry is preferred.
• Ability to build partnerships both internally and externally is required.
• Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
• Prior experience effectively working through periods of change, ambiguity and complexity is preferred.
• Experience thriving in a collaborate work environment is preferred.
• Computer system validation experience is preferred.
• This position is located in Irving, TX and may require up to 20% (international and domestic) travel.
Mentor Worldwide LLC (6177)