Quality Assurance Manager

We are seeking a highly motivated and experienced Quality Assurance Manager to join our team and lead the validation, compliance, and Quality Assurance efforts in our Good Manufacturing Practices (GMP) and Good Agricultural and Collection Practices (GACP) facilities. The successful candidate will play a crucial role in ensuring that our products meet regulatory requirements, maintain the highest quality standards, and adhere to established validation and compliance processes. This position requires a deep understanding of GMP principles, quality systems, and the ability to manage a team of quality professionals.

Key Responsibilities:

1. Validation and Compliance Oversight:

·       Develop and maintain the validation master plan for the GMP facility, including equipment, processes, and systems.

·       Ensure compliance with all relevant regulatory standards, including TGA and ODC and other applicable agencies.

·       Oversee the development and execution of validation protocols and reports, including IQ, OQ, and PQ.

·       Collaborate with cross-functional teams to ensure that all validation and compliance activities are carried out efficiently and according to established procedures.

·       Review and release the batches for sale according to current federal and local regulations and orders.

2. Quality Assurance System Management:

·       Establish and maintain a comprehensive Quality Assurance system that covers all aspects of GMP operations.

·       Implement and maintain Quality Assurance policies and procedures to drive a culture of quality within the facility.

·       Conduct regular internal and external audits to ensure compliance with quality standards and regulatory requirements.

·       Identify and address quality issues through root cause analysis, deviations, and CAPA (Corrective and Preventive Actions).

·       Create and update SOPs to comply with regulations and meet business decisions.

3. Team Leadership and Development:

·       Lead, mentor, and provide guidance to a team of quality professionals, ensuring their ongoing development and performance.

·       Foster a collaborative and proactive working environment within the Quality Assurance team.

·       Ensure effective communication and collaboration with other departments, including production, engineering, and regulatory affairs.

·       Present weekly reports to executives determine duties and priorities.  

       4. Documentation and Record Keeping:

·       Maintain accurate and up-to-date documentation related to validation, compliance, and Quality Assurance activities.

·       Develop and oversee the document control system to ensure that all records are easily accessible and in compliance with regulatory requirements.

• Oversee applications for renewal and obtain permits/licences for various activities.

      5. Continuous Improvement:

·       Continuously assess and improve quality systems and processes to enhance efficiency and effectiveness.

·       Proactively identify areas for improvement and drive initiatives to optimize quality practices.

·       Stay updated on industry best practices, regulatory changes, and emerging trends in GMP to ensure the facility remains in compliance.

Qualifications:

• Bachelor's degree in a relevant scientific or engineering field; advanced degree is a plus.
• Minimum of 5 years of experience in Quality Assurance, validation, and compliance in a GMP environment.
• Strong knowledge of GMP regulations, quality management systems, and validation principles.
• Excellent leadership and team management skills with a track record of building and motivating successful teams.
• Exceptional problem-solving and decision-making abilities.
• Strong communication and interpersonal skills.
• Regulatory affairs experience is a plus.