At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: Legal & Compliance
Job Sub Function: Enterprise Compliance
Job Category: People Leader
All Job Posting Locations: IE007 Castletroy Limerick, US076 FL Jacksonville - 7500 Centurion Pkwy
Job Description:
Job position summary:
* Responsible for directly managing the global internal audit and regulatory compliance functions for J&J Vision Care, including development of goals and assuring management oversight and governance.
* Assure internal audits and assessments are conducted for compliance with the applicable international regulatory requirements (e.g., FDA QSRs, FDA cGMP, ISO 13485, Japanese MHLW, Brazilian ANVISA, EU MDR) for the company's products, including medical devices, combination products, and pharmaceuticals.
* Provide support to the MedTech segment in the performance of audits or audit-related activity.
* Functional responsibilities include internal audits, 3rd party inspection readiness and management, and Quality System compliance training programs.
* Lead and participate on cross-functional and global teams representing key stakeholders in developing and managing policies, standards, and procedures. This includes developing procedures and practices that can be deployed globally.
* Partner with J&J Vision sites and related organizational units to ensure that regulatory compliance procedures are compliant, effective, and efficient. Use partner input to ensure that the overall enterprise objectives are achieved.
* Represent JJV RC and J&J Vision on JJRC teams and working groups. Provide input into segment initiatives. Interpret and integrate resulting segment policies and standards into J&J Vision global operations.
* Manage FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including pre- and post-inspection support, as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
* Manage associated assessment and remediation activities as a result of internal and external assessments. Align and deploy JJV Quality System procedures (worldwide) in accordance with segment and enterprise standards.
* Consult with management, manufacturing, R&D, and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.
* Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues. Interpret and integrate regulatory changes (FDA/ISO/ ANVISA/JPAL/CMDCAS, etc.) into franchise procedures.
* Develop and maintain key quality and regulatory compliance performance metrics. Participate in developing and presenting departmental materials for Management Review.
* Actively participate in continuous improvement efforts for global continuous improvement activities.
* Supervise staff responsible for the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
* Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
* Direct, supervise and train staff of Compliance Specialists/Auditors.
Duties & Responsibilities:
* Manage and lead assessments, analyses, alignment, and implementation activities for regulatory compliance procedures across the organization and provide directional input into segment and/or enterprise standards. (40%)
* Direct, supervise and train staff. Develop and monitor development and training plans. (20%)
* Assist project teams with identification of quality system requirements to ensure compliance with regulations. (10%)
* Acts as liaison with external auditors during third party/regulatory audits. (10%)
* Monitor regulatory agencies for changes in requirements and evaluate impact to the organization. (5%)
* Performs other related duties as assigned by management. (15%)
Experience & Education:
Minimum education required:
* Bachelor’s Degree - Scientific Discipline or equivalent (e.g., RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor).
Minimum experience:
* 8-10 years of related experience and/or training; or MS/Ph.D with 6 or more years; or equivalent combination of education and experience. Prior experience as group leader or manager in a QA or Compliance function.
Required knowledge, skills, abilities, certifications and affiliations:
* Proven track record of successfully leading and/or facilitating FDA inspections, both front room and back room.
* Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas.
* Strong communication, organizational, negotiation and interpersonal skills.
* Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments.
* Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.)
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