Senior Director, Customer Quality, Ethicon and Css

**SUMMARY**:The Senior Director, Customer Quality, Ethicon and CSS, will be responsible for the management and leadership of a global product complaint handling team and EU Vigilance center of excellence. This role supports Ethicon operating companies (multiple franchises), Omrix, and CSS companies for the entire customer complaint process, as well as Regulatory Reporting oversight for Ethicon, CSS and DePuy Synthes.

Responsibilities

include leading a team of individuals through completion of reportability determinations, clinical assessments and justifications as well as timely evaluation, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. The oversight of complaint investigations and MedWatch Reports, EU Vigilance reports, health authority communication, failure analysis, escalating trends and product problems, and remaining abreast of new or revised regulations and/or guidelines.**RESPONSIBILITIES**:Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:- Provide management direction, motivation, and support for department personnel.- Provide leadership to complaint handling staff to ensure complaint files are processed in a uniform and timely manner.- Be responsible for management of employees or contractors at remote work sites, including contract work sites.- Ensure that each staff member has clearly established goals and objectives, monitors staff performance, conducts periodic performance evaluations and compensation planning, and ensures succession planning for key positions, including own.- Develop, coordinate, and otherwise ensures appropriate training for associates.- Ensure individualized developmental plans are in place for all associates.- Review and continuously lead efforts to improve the global complaint handling and pharmacovigilance processes.- Maintain and continuously improve highly effective procedures for complaint processing and complaint investigation.- Develop and maintain product analysis failure analysis methods.- Collaborate with the Field Service Engineering, Medical Safety, Medical Affairs, manufacturing, and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements.- Maintain dashboards and other reports of performance metrics.- Measure key performance indicators to assess the health of the complaint investigation processes.- Provide regular updates and status reports to senior management.- Initiate Product Issue Escalation Process as Required.- Investigate and Documents Complaint Trend Analyses.- Initiate Company CAPA Process as Required.- Coordinate Efforts with J&J Legal Department for Complaints Regarding Litigation and oversees the relationship with all supporting groups specific to litigation complaints.- Oversee Response Communications to Inquiries from Regulators and Health Authorities- Remain Informed of New or Revised Regulations and/or Guidelines and Assesses Impact on Company Complaint Handling and Pharmacovigilance Processes.- Support Internal and External Audits (e.g.

FDA) of Complaint Handling Department.- Serve as a Subject Matter Expert (SME) for Complaint Processing, Complaint Investigation, and Regulatory Reporting as needed during audits and inspections.- Maintain Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.- Executes financial planning and tracking of departmental budgets.- Responsible for communicating business related issues or opportunities to next management level- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures- Performs other duties assigned as needed**Qualifications**QUALIFICATIONS**:- BA/BS/BSN in Scientific, Technical, Engineering, or Nursing field required- Demonstrated leadership capabilities required- Medical Devices/Diagnostics and/or other regulated healthcare industry experience required- Multi-site and matrixed organization experience- 10-12 Years of job related experience required, prior supervisory experience required**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS**:- General Competency in:- QSR/ISO knowledge- Product/Process knowledge- Knowledge in existing Quality Systems- Handles multiple priorities well- Respects confidentiality- Good