Description
One of the world's leading generic and specialty pharmaceutical company based in North Dublin are seeking a Quality director to Lead the site Quality Departments, namely (QA (including Regulatory Compliance), QP and QC. The Quality Director will act as primary contact for regulatory authorities and subject matter expert with respect to all relevant Health Authorities but primarily the Irish Medicines Board.With 3 direct reports the senior QA/QC/QP management team, the successful candidate will have manage and Lead the site Quality Departments (QA, QP and QC) totaling at 80 people.
Reporting directly in to the MD, the Quality Director will initially be involved with some exciting projects some involving NPI and some focused on CI.
The Quality Director will be a quick learner and deal with all stake holders at all levels both on a local, regional and global scale.
Main Accountability:
- Lead and play key role in the interaction with all relevant HA licensing and inspection divisions.
- Ensure adequate provision of the QP release function in line with EU directives for the certification of drug product
- Ensure adequate provision of QC testing function to underwrite GMP operations.
- Ensure that all drug products are manufactured and tested to the requirements of GMP and provide leadership and support to the Quality team to ensure and that any deviations from procedures/instructions and/or abnormal events are investigated and documented and suitable corrective/preventative actions are taken.
- Ensure that all development, manufacturing, packaging, testing and release operations are carried out as required and as stipulated in relevant submissions/authorizations.
- Ensure that adequate resource is provided to carry out Quality reviews and review/approval of GMP documentation.
- Manage the Quality Department within budget expectations
- Ensure that all Quality Systems are efficiently managed and to agreed time lines.
- Ensure that all HSE guidelines are followed with relevant departments.
- Overall responsibility for the handling and storage of Controlled Drugs in accordance with the relevant legislation and procedures to ensure product security.
- Act as Drug Safety Officer and ensure that all ADRs are logged and to communicate effectively with the companies Pharmovigilance Departments.
- Provide leadership to the quality team with regard to annual objective setting and review, individual development plans, career guidance and mentoring.
Skills and Experience:
- 15 years plus in front line experience in pharmaceutical drug product QA/QP/QC/Manufacturing position in a wide portfolio of dosage forms (preferably to include oral solid dose) and hold QP qualification recognised by IMB.
- Experience of front line regulatory interaction (e.g. IMB, FDA, MHRA)
- Extensive Quality/manufacturing experience in commercial drug product manufacturing organisations (preferably acted as QP).
- Have a clear track record of leadership in quality and previous senior management responsibility.
- Must be a clear communicator and able to make clear reasoned decisions under pressure.
- Experienced in the quality oversight of drug product manufacture and analytical testing.
- Experience of managing budgets.
- Have a clear understanding of the practical application of the rules of pharmaceutical GMP.
- Experience in facility, equipment and cleaning commissioning/qualification/validation.
- Experience in "right first time" and continuous improvement philosophies.
- Practical first-hand experience in either: drug product manufacture, analytics or quality management.
Education and Training:
- Educated to degree level and/or 15 years plus experience in pharmaceutical QA/QP/QC/Manufacturing roles.
- Have had previous experience of external influence in the pharmaceutical industry including front line regulatory interaction.
Salary and Package:
A competitive salary alongside a benefits package including, healthcare, pension, bonus, phone, life assurance, education assistance, subsidised canteen.
If you would like to hear more information about the company and role please contact me Anna Mooney for more information.