Quality & Regulatory Affairs Manager

About the job

**Mission of the Job**

This leadership position oversees quality control, quality assurance and quality improvement within the overall Quality Management System (QMS) of the ProbioWorld Laboratory, including the development, review, implementation, and communication of all laboratory quality processes. The Manager ensures the new contract testing laboratory obtains and maintains necessary regulatory licences and approval, including NATA, TGA and others. The Manager provides guidance and consultation concerning quality processes for probiotics, pharmaceutical, and food testing. This position also ensures the development and implementation of internal regulations, guidelines, procedures, etc. with the aim of ensuring that the laboratory complies with the applicable and current legislation and standards locally and internationally, including the International Organization for Standardization (ISO). The Manager supports clients with the listing of products with TGA and getting AUST L number.

Reports to: Managing Director

**Key Responsibility Areas**
- Lead the quality and regulatory processes to obtain licences and accreditation for the laboratory
- Ensure compliance with laboratory accreditation, regulatory standards and information management policies by providing leadership and guidance to staff to ensure that quality policies, processes and procedures are established, current and adhered to by all laboratory staff.
- Guarantee the quality within the entire flow, from sample receipt to product testing and result release, with the aim of continuously attaining optimal quality.
- Prepare and Oversee internal audit processes, external assessments, proficiency testing programs; document control systems; competency assessment; training and other quality processes with the aim of effecting ongoing improvement to quality and processes.
- Identify training needs, as well as design and implement training programs specific to the quality system
- Manage, organize and schedule all quality operations within the laboratory with the aim of meeting the prescribed quality standards.
- Maintain, update and implement processes with the aim of receiving local and international approval for services and products
- Verify that all regulatory policies and procedures have been documented, implemented and communicated with the aim of making sure every employee knows the applicable procedures and works accordingly
- Maintain good contacts with authorities with the aim of anticipating on changes or new developments and trends within the companies serviced by the laboratory.
- Stay well-informed about the evolutions and developments, keep knowledge up-to-date within the context of the amendments to regulations with the aim of strengthening credibility by offering a service that is continuously based on updated knowledge.
- Act as a contact for local authorities as regards quality with the aim of creating constructive and honest communication with the various partners
- File appropriate compliance reports with regulatory agencies with the aim of working following applicable regulation
- Maintain compliance and timely registration for licensing and products associated with the business
- Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
- Conduct or direct periodic internal reviews or audits with the aim of ensuring that compliance procedures are followed
- Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitate laboratory improvement activities.
- Analyse data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and laboratory experience.
- Monitor customer satisfaction and performance metrics.
- Identify and report quality issues and problems to management with recommendations for resolution.
- May supervise others and provide input into financial, safety and procurement decisions.

**Job Position Competencies**

**Quality Management Systems**
- Ensure that the laboratory’s organizational structure is committed to achieving and maintaining quality, advocating for a culture of quality, safety and ethics, and analyzing quality measures to evaluate the costs of maintaining quality
- Ensure that laboratory personnel and instrumentation meet performance standards
- Ensure that there is an effective system to control and manage documents and records
- Develop and ensure that processes and procedures are in place for detecting and managing nonconforming events, and performing internal audits and external assessments
- Develop and ensure mechanisms for continuous quality improvement

**Laboratory Practice**
- Demonstrate knowledge and skills related to the scientific and technical components of laboratory testing in order to oversee the po