Description
Pharmaceutical company based in Dublin Seeking a Vice president of QA and RA.Reporting directly to company CEO the VP Q.A. R.A. will be a Member of the company Management Team and provide input into business strategy in particular 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.
Responsibilities include, but are not limited to:
Head of Quality Unit:
*Implement and maintain a Quality Management System (QMS)
*Ensure that the company is inspection ready at all times
*Management of authorized activities, ensure accuracy, quality and maintenance of records
*Ensure adherence to FDA/EU and local laws and regulations
*Manage CMOs and sub-contractors including approval of suppliers and audits for GMP compliance
*Manage team of professionals across multiple locations
*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
*Manage global QMS including writing of SOPs, update and maintenance of QMS, quality manual and SOPs, training of personnel. Ensure compliance to all relevant standards within the company, including, but not limited to the following systems: Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, SOP Training
*Ensure the company, its third party contractors and service providers operate in compliance with QMS
*Vendor selection, audit and management
*Preparation for, participation in and follow up on inspections by regulatory authorities *Chair change control committee, product recall committee and other ad hoc committees as needed
Regulatory Affairs:
*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
Person Specifications:
-Bachelor's 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 with and fundamental understanding of FDA regulations and guidance documents.
-Experience leading GMP audits, including drug product manufacturing and analytical testing sites.
-Process validation and/or IT compliance.
-Experience in defending processes, procedures and investigation during regulatory inspections desirable.
-Able to interact readily and easily with key contacts (e.g. different functional groups) with strong interpersonal skills and professional skills to interact at all levels.
-A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity.
-Must be able to travel up to 25%, primarily to the USA.
-Experience interfacing with regulatory bodies and working on regulatory submissions.
If you are interested in this great opportunity and have the right skill set and experiene please contact me Anna Mooney or apply below with an up to date CV.