Yacht Life Sciences has a vacancy for a Regulatory Compliance at Johnson & Johnson Vision in Groningen.
J&J Surgical Vision in Groningen is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacture of these products.
- 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 JJV 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.
- Partner with stakeholders and business partners to assess risk and establish proactive risk mitigation strategies and enable innovation in emerging areas.
- 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 FUNCTIONS / 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%)
- Bachelor’s Degree - Scientific Discipline or equivalent (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor).
- Minimum of 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.)
- Knowledge of IT internal controls, software development lifecycle (SDLC) methodologies, data integrity requirements, as well as general knowledge of cybersecurity and Medical Device software is a preferred skill.
- 4 years Experience in compliance
- 3 years of Experience in auditing
- Knowledge in regulation
- Medical devise experience
- English (required); dutch (preferred)
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a secondment contract for 1 year via Yacht with an assignment at J&J Vision for at least 6 months (extension is anticipated). Salary between 4500 and 5200 euro gross per 4 week period.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Johnson & Johnson Vision Care, part of Johnson & Johnson Medical B.V. is committed to transforming eyesight in the world. Johnson & Johnson Vision (formerly AMO Groningen BV) has been set up as a Center of Excellence to develop, improve, prepare and produce innovative solutions for surgical ophthalmology - mainly intraocular lenses (IOLs). The organization is divided into 5 core teams that work largely on a project basis and according to strict quality guidelines in an international environment. The organization is growing strongly due to an increase in projects and production volume.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.