Johnson & Johnson's Neurovascular Division (CNV), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Compliance Manager. The position can be located in either Miami, Miramar, FL or Fremont, CAlocations.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Johnson & Johnson's Neurovascular (CNV) Division is one of the leaders in the medical device industry. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.
Primarily responsible for support and management of the compliance program, ensuring that the Company is in compliance to regulatory requirements and internal procedures. You will provide compliance support in the specific areas of Internal Audits, External Audits, and Audit Readiness, and ensure ongoing effectiveness of these systems. This position develops and coordinates plans to identify, address and mitigate potential risks to compliance to support Company's activities.
- You'll collaborate with business partners to ensure compliance to all regulatory requirements, standard requirements, and internal procedures.
- Establish, evaluate and maintain the internal audit program to ensures quality management systems are operating in compliance; develop and manage audit plans; conducts audits, develop metrics and compile data on audit results, issues or trends and corrective actions, and presents to management.
- Ensure adherence to the internal audit schedule, ensure qualified personnel perform the audits and generate timely audit reports, and support auditees with investigations and action plans in response to the audit observations.
- This position will ensure timely identification and escalation of compliance gaps observed during internal audits.
- Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
- Participation in task force teams to improvement quality management systems, and participate in facility assessments at other J&J companies as assigned.
- Audit/Inspection Readiness: Supports Company efforts in the preparatory activities for external audits and regulatory inspections.
- Supports teams and functions in activities following external audits and regulatory inspections, including reviewing and/or approving the responses to observations prior to submission to sponsors and regulatory agencies.
- Provide training to applicable functions on audit and inspection readiness. Conduct and/or support mock inspections.
- Assist in achieving the Company's goal of being inspection ready at all times on external and Customer Audit Support: Manage, coordinate, and document audits as assigned.
- If applicable, supervise compliance auditor(s) according to Human Resources policies and procedures, including hiring, training, and performance appraisals.
- If applicable, the position will provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities, including compliance with Health and Safety requirements.
- A minimum of a Bachelor's Degree, preferably a Masters Degree in science, business, engineering, or related field
- 8+ years of experience in Quality Systems
- 3+ years of experience supporting FDA audits and managing direct reports at a supervisor or manager level
- Working Knowledge of 21 CFR Part 820, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP
- Ability to interpret and apply regulatory requirements and industry best practices.
- Critical thinker, detailed oriented, while overseeing multiple tasks for several projects
- Experienced Internal/External Auditor
- Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc
- Prepare and present written correspondence, reports, and materials in a clear, correct and comprehensible manner
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Strong organizational, interpersonal and collaborative skills
- Ability to deal with pressure and provide constructive feedback
- Ability to influence management and partner effectively across Operating Units
- Capable of building internal and external partnerships
- Microsoft Office (Outlook, Word, Excel, PowerPoint, Access)
- Travel up to 30%, both domestic and international
- ERP Systems; EDMS; LIMS; EQMS
- Experience in the medical devices or pharmaceutical industry
- Experience working in a global business environment
- ASQ CQA Certification or Lead Auditor
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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