Collins McNicholas is an Irish based recruitment agency which has over two decades of experience in recruiting at all levels for an extensive client base.
With five offices in Dublin, Cork, Galway, Sligo and Athlone, Collins McNicholas is a nationwide recruiter for permanent, temp and contract staff for our client base of multi-nationals, SME's, Indigenous companies and Public Sector clients.
Director of Quality Job Description
Director of Quality
Looking to explore a new career opportunity? Why not move to the beautiful and vibrant city of Galway in the West of Ireland!
Recently Galway has been awarded Capital of Culture in 2020. From the mesmerising hills and landscapes of Connemara to the beautiful sandy beaches in Galway Bay, the west of Ireland has a lot to offer. Galway is a youthful, diverse, energetic city with its Universities and colleges containing 23000 students. The city has an endless supply of pubs, club, museums, sport clubs, theatres, parks and guided tours. Galway is also known for its festivals such as the Galway Races, Galway Arts Festival and Oyster festivals which generate people from all over the world to join in the festivities.
The west of Ireland has also become an industry hub for sectors in pharmaceutical, medical and ICT companies. This is not surprising as companies such as Google, Facebook, Twitter, Uber, Yahoo having their Headquarters in Ireland.
Galway can provide huge opportunities in the growth and development of your career. Why not apply to our jobs which can create a new and exciting adventure for you in Galway, while you have the chance to experience and explore the rich Irish culture.
ROLE AND RESPONSIBLITIES
- 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.
Director of Quality Job Requirements
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 client offers 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 an Equal Opportunity Employer.
Director of Quality Application Information
Please apply with your CV and cover letter by the 'apply' button below
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Director of Quality Summary
10 - 15 years
5 - 10 Years
> 15 years