Johnson & Johnson Careers

Staff Compliance Specialist

Limerick, Ireland
Regulatory Compliance


Job Description

Requisition ID: 1700210605W

Position Title:Staff Compliance Specialist

Department:Regulatory Compliance

Report to: Senior Manager, Regulatory Compliance

Location: Vision Care, Limerick

 

Company Summary:

Johnson & Johnson Vision Care Ireland is located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 800 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.

 

Johnson & Johnson Vision Care Ireland was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 31 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.

 

Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.

 

Position Summary:

·         Plan, coordinate, and conduct quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements.  Facilities include worldwide operations, including the United States, Europe, and Asia.

·         Provide support to the CMD segment in the performance of audits or audit related activity.

·         Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures.

·         Review and monitor required corrective actions; conduct follow-up activities on required action items.

·         Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.

·         Providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general 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.

·         Consult with management, manufacturing, R&D, marketing company 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.

·         Develop and maintain key quality and compliance performance metrics.  Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.

·         Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J Vision portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.

·         Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization.  Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.

Essential Responsibilities:

·         Conducts internal and external QSR/GMP/ISO quality system audits and follow-up activities. (50%)

·         Assists project teams with identification of quality system requirements to ensure compliance. (15%)

·         Acts as liaison with external auditors during third party/regulatory audits. (10%)

·         Monitors regulatory agencies for changes in requirements and evaluates impact to the organization. (5%)

·         Performs other related duties as assigned by management. (20%)


Qualifications

Education and Experience:

Essential:

·         Bachelors Degree - Scientific/Engineering Discipline or equivalent (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor).

·         Minimum of 2 - 4 years of working experience in the quality assurance / compliance audit environment.  Minimum of 3 years auditing experience.  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.)


Primary Location
Ireland-Limerick-Limerick
Organization
Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function
Regulatory Compliance
Requisition ID
1700210605W