Assoc Dir, Quality

Assoc Dir, Quality

AbbVie

Galway, Ireland

Job Summary

The Associate Director, Quality is responsible for developing, implementing and maintaining site compliance strategies and Quality Systems. The Associate Director is responsible for staying current with proposed and implemented regulations and understanding industry trends. This position interfaces and collaborates with corporate and other site management in assuring that the site is fully compliant with relevant regulatory standards. The Associate Director is responsible for transitioning developmental products into Quality Systems and overseeing compliance. The Associate Director is a key participant in site regulatory agency inspections. This position manages a team of QC Technicians, Manager, Quality Control, Manager, Quality Engineering and the Quality Systems Analyst.

Job Responsibilities

  • Provide strategic and tactical direction for Quality Systems design and maintenance;
  • Manage key site quality systems such as Change Control, NCMRs, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control, Labeling Artwork Approval, Technical Agreements, etc. Measure and report site performance on key indicators of these quality systems through metrics;
  • Ensure quality system performance is appropriately and well communicated throughout site;
  • Provide guidance and assessments on other site Quality Systems;
  • Ensure site applicable aspects of regulatory submissions are appropriately reviewed for consistency between site procedures and methods and regulatory submissions.
  • Ensure site compliance with relevant Medical Device regulations;
  • Lead and direct critical root cause problem-solving investigations;
  • Develop and sustain a culture of constant site readiness for site inspections. Identify industry trends and implementation strategies to keep the site ahead of the compliance curve and within Allergan’s budgetary requirements;
  • Develop a support/service mentality in Quality staff, partnering with local site departments;
  • Serve as a key participant in site regulatory agency inspections;
  • Support daily activities, ensuring Quality personnel execute their work in strict accordance with SOPs, and cGMP guidelines;
  • Seek process innovation and continuous process improvement in Quality function;
  • Allocate and coordinate personnel resources to all Quality compliance activities and provide direction to ensure that specified targets for team are met;
  • Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives;
  • Contribute to the continual improvement of Quality documentation and ensure that they are current, accurate, and clearly define process and role responsibilities;
  • Provide hands on training, support, and coaching to reports and make timely decisions to ensure that performance targets can be met;
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training.

Qualifications

Essential Knowledge & Experience

  • Bachelor’s degree in biological science or engineering (mechanical, industrial, chemical, electrical) is preferred;
  • Minimum of 5 years of experience managing Quality in an FDA/ISO regulated Manufacturing Environment;
  • Strong knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards relevant to medical device manufacturing;
  • Must have excellent understanding of current Good Manufacturing Practices and manufacturing operations;
  • Experienced and knowledgeable in EU and FDA cGMPs;
  • Proven history interacting with regulatory authority inspectors;
  • Managing and driving KPIs;
  • Experienced in aligning individuals and teams to business objectives;
  • Exposure to Lean manufacturing concepts;
  • Ability to focus on and achieve scheduled milestones, including contingency planning;
  • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed;
  • Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint and Outlook;
  • Ability to write reports, specifications, business correspondence, and procedure manuals in English.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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