Head Of Quality

ABOUT THE COMPANY

UA Manufacturing is a new subsidiary located in Altona North Melbourne, invested by Uniasia Cosmetics Technology, a world-famous international cosmetics manufacturer. 

Specializing in the procurement, development, manufacturing, filling and packing of beauty and cosmetics products, we are passionate about cosmetics and beauty, and committed to offering superior and value-added services, such as product development, custom formulation and manufacturing solutions.

Our state-of-the-art facility has been built in strict accordance with TGA, GMP, ISO9001:2015, ISO 22716:2007 regulations and to meet the standard of a 100,000-purification factory. This ensures we have a superior clean production environment in our facility. In addition, we have sourced the world's leading automated production equipment which greatly enhances our production efficiency, saving on our client's time and costs.

As one of the largest cosmetic OEM in Australia we have a rapidly expanding customer base. At UA Manufacturing you can grow and develop as we do.

SUMMARY OF ROLE

The Head of Quality is entrusted with the leadership of the Quality Management System (QMS), focusing on its alignment with both Therapeutic Goods Administration (TGA) guidelines, especially sunscreen products and Good Manufacturing Practice (GMP). The role involves ensuring that the organization's products and development processes not only meet regulatory and quality requirements but also embody the principles of GMP to guarantee product safety and efficacy.

KEY RESULT AREAS AND ASSOCIATED TASKS/ACTIVITIES

QMS development and maintenance

• Develop implement and maintain a robust QMS that complies with both TGA regulations and GMP standards, fostering a culture of Quality and continuous improvement.
• Design and implement GMP-focused training programs for key personnel in conjunction with relevant managers, implement training programs in production and quality management in collaboration with HR department, ensuring comprehensive understanding and adherence to quality and safety standards.

Regulatory and GMP Compliance

• Lead the organization through TGA certification processes, ensuring audit readiness and seamless compliance with all regulatory and quality standards.
• Act as the primary point of contact for audits and inspections related to TGA, managing pre-audit preparations and post-audit follow-ups, including but not limited to ISO9001, GMP(ISO22716), COSMOS, SMETA, etc.
• Manage internal and external support program audits (such as 2nd party audit from clients) including the corrective action request process and system.
• Represent the company to ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force and in accordance with the requirements of the Marketing Authorization.

Internal Quality Oversight

• Regularly review and report on the QMS performance with an emphasis on GMP compliance, identifying areas for improvement and ensuring adherence to all regulatory standards.
• Conduct thorough internal audits and management reviews to assess and enhance GMP compliance within all operational aspects.
• Support production targets whilst maintaining plant and product standards and specifications. Report to management on performance of the QMS, highlighting areas for improvement.
• Formulate and maintain quality objectives complementary to corporate policies and goals.

Supplier and Customer Engagement

• Implement rigorous supplier quality management programs in line with TGA requirements, conducting audits and assessments to ensure supplier compliance.
• Address and resolve customer complaints with a focus on continuous improvement and customer satisfaction, adhering to GMP and TGA standards.

Quality Control and Improvement

• Work in close collaboration with the Quality Control team to manage quality deviations, implementing GMP-compliant corrective actions and preventive measures.
• Lead continuous improvement initiatives, leveraging GMP principles to enhance quality systems, processes, and outcomes.

Documentation and GMP Record-Keeping

• Maintain meticulous documentation and records management in accordance with TGA guidelines, ensuring all data and processes are accurately recorded and archived.
• Examine and file all kinds of production records.

Compliance Advisory and Support

• Offer expert advice and support on GMP and TGA compliance to internal teams and external partners, facilitating compliance projects and technical collaborations.

Compliance project and technical service for internal & external brands -assisting Business development

• Evaluate and/or prepare documentation based on current regulations and/or requirements.
• Ensure ongoing compliance with quality and industry regulatory requirements.
• Communicate with the BD, R&D team and assist as needed; Cooperate with external customers to complete various requests, such as collecting and organizing documents, cooperating with the completion of product certification projects, etc.
• Responsible for various compliance programs for the internal brand and external brands, such as official registration in other countries, various certificates, etc.

OTHER REQUIREMENTS 

Experience/Knowledge Required 

• Bachelor's degree in a relevant scientific, pharmaceutical, or engineering field. Additional qualifications or certifications in quality management systems, regulatory affairs, or a related discipline are highly desirable.
• A minimum of five years of progressive experience in quality management roles within the pharmaceutical, biotechnology, or related industry, with a strong emphasis on compliance with regulatory standards.
• Demonstrated experience in implementing, managing, and enhancing Quality Management Systems (QMS) in accordance with TGA guidelines and Good Manufacturing Practice (GMP) standards.
• Proven track record in successfully leading and managing TGA compliance initiatives, audits, and inspections, including preparation, execution, and follow-up actions.
• In-depth understanding of TGA regulatory requirements, guidelines, and legislation relevant to the manufacturing and control of therapeutic goods.
• Familiarity with international quality and regulatory standards (e.g., GMP, ISO) that complement TGA requirements, enhancing the organization's compliance and quality assurance capabilities.
• Ability to interpret and apply regulatory guidelines to operational processes and quality management practices, ensuring consistent compliance.

Technical Capability 

• Proficiency in risk management, quality assurance methodologies, and continuous improvement techniques.
• Strong competency in data analysis, statistical methods, and quality control processes that are critical for ensuring product quality and safety.
• Advanced computer skills, particularly in quality management software, Microsoft Office Suite, and other tools relevant to quality documentation and record-keeping.

Behavioral Competencies

• Exceptional leadership and team management skills, with the ability to inspire, motivate, and guide teams towards achieving quality and compliance objectives.
• Excellent communication and interpersonal skills, capable of effectively interacting with regulatory authorities, internal teams, and external partners.
• Strong problem-solving abilities, attention to detail, and organizational skills, essential for managing complex regulatory and quality challenges.
• A proactive and adaptable approach, with a commitment to continuous learning and professional development in the field of Quality management and regulatory compliance.

Please submit your application in SEEK if this is the next challenge you are looking for.