Quality Assurance Manager

CPL

Dublin North

Manager, Inspection Management My client is a Global Pharmaceutical company based in Dublin North and is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world and in conjunction with the CPL Group is looking to recruit for a Quality Assurance Manager of Inspection Management. Responsibilities. The role is a new created position and in the role, you will be involved in supporting the 15 plus sites, this position will provide expertise, guidance, and support to our manufacturing sites (and/or key strategic business partners as determined by business need) by interpreting governmental regulations and guidelines, as well as internal and corporate policies to ensure compliance, efficiency, and effectiveness. Maintains expertise in current and emerging cGMP requirements and quality trends as they relate to Class III medical devices, combination products, biologics and solid dosage worldwide. Scan external environment to assess GMP inspection trends and findings and assist Corporate and Site Quality Management to develop effective strategies to address and/or incorporate data from Regulatory Intelligence. Inspection readiness of the sites before the inspection to ensure the site logistics are adequate for the upcoming audits, setting up the facility and defining roles and responsibilities, preparing the sites proactively for handling of major deviations, complaints or other major product or systems issues. Support the sites on Regulatory Agencies inspections such as USFDA, MHRA, HPRA, TGA, ANVISA, BIMO for IDE and IND submissions, State inspections for medical devices, CDC, USDA etc. Acts as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards and notified body inspections. Adapt and implement global improvements that arise through remediation efforts (i.e., responses to regulatory authority objectionable findings, internal audit findings, and/or agreed self-identified continuous improvement opportunities. Qualifications: A strong familiarity with domestic and international regulatory compliance regulations and an understanding of the pharmaceutical product lifecycle (development, technology transfer, analytical methods, laboratory operations, manufacturing/packaging operations, distribution, etc.) are important. Knowledge of regulatory, legal, ethics, guidelines and compliance in the Life Sciences industry and proactively stays abreast of emerging compliance trends in the pharmaceutical, biotechnology and medical devices sectors (as required by the business. Experience with Compliance Programs, including developing policies and procedures, compliance training, investigations, implementations, enforcement activities and monitoring. Demonstrated ability to effectively develop, communicate and gain support for strategic plans from wide range of stakeholders. Global pharma/medical devices operational experience and working knowledge of regulatory and operating requirements in a global setting. Role has a requirement to interact closely with internal and external business partners and customers/suppliers. Negotiation and influencing skills are required. Broad understanding of US and International regulations including 21 CFR 820. May require domestic and international travel (25-50%) Bachelor's degree required. Preferred Education: MA/MS in Microbiology or Chemistry. 10-12 years of Quality experience in a medical device, combination products and/or biologics environment including auditing and regulatory inspection experience. Suitable applications should email their cv to aileen.cahill@cpl.i or call me on 016146007 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2439 days ago