Director Of Quality

Collins Mcnicholas Recruitment

Galway

Responsibilities. The Director of Quality will be responsible for the Injectables Quality Operations, Galway site, to ensure that high quality products leaves the site. Working closely with other functions to ensure that a very high standard of quality is maintained and supported by robust systems. Direct responsibility for the correct and compliant execution of all aspects of Quality/Quality Management System. Staying abreast of regulatory and compliance developments, communication of such trends and directions to the site (and Global Quality where applicable), ensuring that the appropriate action plans to achieve and maintain compliance is in place. To support the sites Qualified Persons as per EU Directives 2001/83/EC, 2001/82/EC and 2001/20EC (including any subsequent amendments) for release of Pharmaceutical Products/Investigational Medicinal Products to the market with respect to the Manufacturing License’s and to stay current with state of the art standards for the industry. Ensure the manufacture of drug products and finished product are performed in a safe, compliant manner, meeting the regulatory requirements defined in the Procedures and Directives; relevant health authority submissions; cGMP and local Health & Safety requirements. Provide strategic and tactical leadership input to the internal operations organization for the manufacture of our clients commercial and development products. Direct strategic planning and the development of goals, objectives, and policies for the Quality group in consultation with the Head of Global Injectables Quality Operations, Head of Injectables Site Operations, and the site Leadership Team. Determine group structure; ensure the development of talent for leadership roles; plan talent succession and carry out performance assessments of department sub-ordinates. Provide effective Quality leadership during internal and regulatory inspections and to participate in the Internal and External Auditing Program. Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes, but is not limited to: Laboratory Process optimization, Operational Excellence compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum etc.). Manage and maintain robust relationships with our internal leadership team, industry colleagues and with the HPRA & FDA organizations. Qualifications. Here are the minimum qualifications and essential functions for this position: Must possess knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial and Clinical Injectable products. Minimum of a Bachelor's degree (or equivalent) and a minimum of 8 years of Quality Management experience in a leadership role managing quality operations within the pharmaceutical industry. A Master’s degree and aseptic processing experience is highly preferred. However, a combination of experience and/or education will be taken into consideration. Qualified Person Status preferred. The experience and passion to contribute positively to the professional development of a high performing team is a must. Our clientoffers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Our client is anEqual Opportunity Employer. This job originally appeared on RecruitIreland.com.

2619 days ago