Quality Head - Pharma

Job Description

Quality Head - BiotechExciting opportunity for experienced Quality professionals to lead Quality team at our Roscommon, Ireland facility- Ideal for candidates with 15 - 20 years of experience in pharma or medical device manufacturing seeking international leadership exposure.ROLE:- Point of contact to authorities as Management Representative Set direction and identify priorities regarding Compliance and Regulatory.- Employees are expected to support the quality conceptsincluding a variety of job-related tasks which may not be specific to this position profile.ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:Leadership:- Set Quality Objectives and goals for the Quality Management System and site that are aligned to the site strategy.- Implement and maintain the Quality Management System in line with ISOrequirements, and other relevant regulatory requirements and ensure that the site is audit ready at all times.- Ensure that a monitoring system is in place to ensure our Quality Management System is kept in compliance and updated as necessary in line with regulatory changes.- Ensure quality and regulatory personnel are competent in the activities performed as part of ISO 13485, FDA, MDR and customer requirements.- Ensure implementation and effective management of Quality Management System elements including: Internal Audit program, Document Control, Change Management, Validation, Non conformance management, CAPA, Deviation, Supplier Management, Risk Management, Complaint Management, Vigilance and Post Market Surveillance:.- Lead on-site regulatory inspections as Management Representative.- Ensure that requirements related to incoming inspection, in process inspection and product release are implemented and effectively managed.- Ensure that product packaging, labelling and IFU requirements are understood and implemented and that artwork is kept up to date.- Ensure that requirements for sterilization of product and environmental monitoring are implemented and effectively managed.- Ensures that Management Review is performed as required by relevant site procedures.- Ensures that site Quality metrics and KPIs are developed, reviewed and evaluated.- Leads assigned global quality projects and compliance initiatives where necessary.- Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.- Provide leadership and development to the organization to maximize effectiveness and assist development of employees concerning the Quality Management System.- Acts as site responsible person for Vigilance activities including reviewing of complaints for vigilance determination, initiating reporting and vigilance activities.EXPERIENCE:- Excellent working knowledge of Quality System Requirements such as ISO 13485 , FDA 21 CFR and the MDR regulations.- At least 5 years experience in a senior leadership position.COMPETENCIES REQUIRED:- Experience in working in a high volume medical device production facility.- Strong computer skills Change control management; Design Control, and process control including the use of automated management systems.- Certification as an auditor to ISO 13845 is highly desired.- Good customer relation skills.- Ability to present an independent opinion.- Quality of work / attention to detail; maintains high standards despite pressing deadlines.- Problem Solving (using recognized tools) and decision making (makes sound factual decisions).Interested can share your updated resume on this id hidden_email

Keyskills :
process excellencequality operationsquality controlquality assurance