QUALITY & REGULATORY MANAGER / RESPONSIBLE PERSON required by CareerWise Recruitment for our multinational generic pharmaceutical client in Cork. Under broad administrative direction of the Managing Director the QUALITY & REGULATORY MANAGER & Responsible Person (RP) is responsible for the Quality Management System and Good Distribution Practices (GDP).
The QUALITY & REGULATORY MANAGER / RESPONSIBLE PERSON Directly manages day-to-day quality management & Good Distribution Practices (GDP) operations and facilitating resolution of issues. The RP at the site should have sufficient knowledge of GDP to conduct the role. This should include a knowledge of the EU GDP Guidelines, the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 539 of 2007), as amended, and any supplementary guidance issued by the HPRA. The RP should be familiar with the wholesale activities conducted at the site and be continuously contactable.
Role of this position
- Owner of the quality system and ensures that it demonstrates adherence to Good Distribution Practices (GDP's) and AmerisourceBergen Policies and procedures.
- Lead the negotiation of technical aspects of the transactions to help lengthen the life cycle of products as appropriate in existing and/or new markets.
- Manage and monitor the implementation of existing & new quality related contracts and fulfillment of the organization's contractual rights and technical obligations focusing on driving profitable growth while maintaining compliance.
- Address and resolve quality events to solve problems and improve systems by working with internal and external parties, develop and implement corrective and preventative actions and document quality event resolution.
- Oversee outsourcing and internal audits using data to identify opportunities and improved processes.
- Ensure that supplier's & customers are qualified as per internal procedures.
- Approves all outsourcing, suppliers and customers prior to use and ensures that suppliers & customers bona fides are obtained and accurate. This includes ensuring that a technical/Quality agreement is in place were required.
- Ensures that there is an annual review of supplier and customers bona fides.
- Manage the Corrective & Preventive Action process and ensure effective CAPA's are implemented following identification of a root cause.
- Host external audits with regulatory agencies and close out any findings in a timely manner.
- Prepare, perform, and review financial and business analysis/date to ensure efficient, cost competitive execution of development, technical and quality projects.
- Responsible for all associate relations functions for staff including hiring, terminations, performance management, development and training.
- Manage the Quality System to control and maintain updated Regulatory Documentation.
- Ensure that all good distribution records are maintained, and records are accurate
- Liaise with regulatory authorities as required to ensure appropriate registrations & licenses are up to date & in compliance.
- Manages the Quality Management Review process and ensures periodic reviews are conducted.
- Approves change controls, self-inspections, deviations, recalls and customer complaints.
- Responsible to ensure that product recalls are coordinated & conducted when required in a prompt manner.
- Responsible for the management of customer & supplier complaints.
- Manage & develop the key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
- Manage the electronic Document Management Application and identify areas for development to improve productivity.
- Ensure personnel receive induction training and ongoing GDP training.
- Ensure personnel follow all health & safety policies and procedures.
- Keep up to date with all relevant regulatory updates and update the quality management system to ensure compliance.
- Performs related duties as assigned.
- BS in a scientific discipline preferred; minimum of five (5) years in a cGMP/GDP facility in a Quality Assurance/Regulatory role.
- The preferred candidate must have experience in auditing in an international environment and Responsible Person experience as per the EU GDP Guidelines.
- Previous experience in managing or supervising direct reports is essential
- Excellent oral and written communication skills
- Knowledge of the EU GDP guidelines for Medicinal Products (Control of Wholesale Distribution) Regulations.
- Ability to effectively manage and participate in cross-functional problem solving teams
- Ability to read and understand the English language for the purpose of following instructions
- Strong leadership skills and ability to lead cross-functional teams
- Ability to develop and maintain cooperative working relationships with others.
- Ability to use good judgment in order to carry out detailed instructions
- Ability to work independently
- Excellent teamwork and interpersonal skills
- Ability to handle a variety of tasks simultaneously
- Be willing and available for international travel as needed to meet business needs.
Please call Conor Twomey today for further information on 087-0907204 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)