Job Description
Based in Dublin, the Director of Q.A. R.A. Ireland will be a member of the company Senior Management Team and provide quality and regulatory management oversight for Ireland's licensed products. The individual will also be responsible for development assets. The company's flagship program, which is currently in Phase 3 clinical trials. The individual will provide support for diligence activities in respect of potential commercial or development stage product acquisitions. Current commercial activities are performed by contractors both in the United States and Europe, approved by the Quality Function.
The ideal candidate will possess the experience and knowledge of EU and US regulations to ensure that the company's activities are performed to the highest standard of quality and regulatory compliance and will be comfortable with a hands-on approach required to achieve the goals of a growing, ambitious company. A level of travel can be expected, typically up to 6 international trips per year.
Reports to: Local: A Board Director
Job Specification and Key Responsibilities:
The role will be wide and varied. Responsibilities will include but are not limited to:
Quality:
· Manage the team of Senior QA Managers based in Dublin.
· Implement and maintain a Quality Management System (QMS) that operates effectively with a range of third-party contractors' quality systems.
· Ensure that the company is always inspection ready including preparation for, participation in and follow up on inspections by regulatory authorities.
· Management of validation and stability programs
· Day to day management of authorised activities, ensure accuracy, quality and maintenance of records.
· Ensure adherence to FDA/EU and local laws and regulations.
· Manage CMOs and sub-contractors including vendor selection, approval of suppliers and audits for GMP compliance.
· Lead Quality and Regulatory aspects of due diligence projects.
· Maintain appropriate Quality or Technical agreements with all GxP vendors.
· Develop, implement and manage Pharmacovigilance, Medical Information and Product Complaint processes and reporting.
· Ensure compliance of external sites to internal and regulatory guidelines
· Ensure the organisation understands the product risk associated with compliance and quality and minimise such risk.
· Ensure the best quality standards are applied to company products.
· Chair change control committee, product recall committee and other ad hoc committees as needed.
Regulatory Affairs: 2
· Overall responsibility for ensuring ANDA/NDA compliance with regulatory approvals for products marketed by the company.
· Preparation of annual reports, annual product reviews and other communications with FDA
· Management of Quality Assurance and Regulatory Affairs team members in creation of above documents, readiness for regulatory inspections, ad/promo review and other duties as assigned.
Technology Transfer:
· Manage technology transfer activities to meet company expectations regarding CMC, manufacturing process reliability, project schedule and costs.
Requirements of the Position:
Skills, Qualifications and Experience
NFQ Level 8 or preferably NFQ Level 9 degree in chemistry, biology, pharmacy or a related discipline
Significant experience (15 + years) working in pharmaceutical finished product manufacturing with experience in compliance, quality assurance, quality control, and regulatory development.
Experience interfacing with regulatory bodies and working on regulatory submissions.
Thorough understanding of quality systems and cGMPs
Experience with and fundamental understanding of FDA regulations and guidance documents.
Experience leading GMP audits, including drug product manufacturing and analytical testing sites.
Process validation compliance.
Knowledge of US device regulations would be an advantage.
Experience in defending processes, procedures and investigation during regulatory inspections desirable.
Professional written and oral communication skills including presentations skills.
Competencies
Able to interact and foster excellent working relationships readily and easily with key contacts cross functionally at all levels with strong interpersonal and professional skills.
A true self starter who works effectively on their own initiative is resilient and is used to working in demanding environments where there is continuous change and ambiguity.
Good, highly motivated leader
Critical thinker with analytical mind and a strong ability to evaluate process problems.
Very organised, with exceptional time management and prioritisation skills
For further information on this Director QA & Regulatory Affairs position please contact Laurentina Kennedy at The RFT Group on 01 2302400 /. Check out all our open jobs on our Recruitment website: