About the job

Cauldron is seeking a dynamic individual for the role of Quality and Regulatory Manager, reporting directly to the R&D Plant Manager. As the Quality and Regulatory Manager, you will be at the forefront of ensuring operational excellence and regulatory compliance in delivering superior products and customer experiences. This role will involve orchestrating essential projects within Cauldron, with a strong emphasis on quality management, regulatory adherence, and customer satisfaction.

Role Responsibilities

The Quality and Regulatory Manager will be responsible for a range of core responsibilities aimed at increasing Cauldron’s value through expansion of Cauldron’s addressable market and Quality excellence. Your expertise will shape and define this pivotal position, focusing on:

Financial Management

● Collaborate with Finance teams to develop accurate cost projections for quality and regulatory initiatives, ensuring alignment with budgetary constraints.

● Provide financial insights during contract negotiations to ensure that regulatory and quality requirements are balanced with financial objectives.

Monitor expenditures related to quality and regulatory compliance efforts, optimizing resource allocation for successful outcomes.

Project Management

● Develop and oversee comprehensive project plans for quality and regulatory initiatives, outlining goals, milestones, and key actions for successful implementation.

● Coordinate cross-functional teams to ensure alignment and effective execution of quality and regulatory strategies.

● Regularly analyse project data to assess effectiveness, identify trends, and adjust approaches to achieve optimal results in compliance and quality enhancement.

Governance and Risk

● Proactively identify potential regulatory risks within customer interactions and develop strategies to mitigate escalations or non-compliance.

● Ensure adherence to contractual agreements and regulatory standards, working closely with legal and compliance teams to verify accuracy and mitigate risks.

● Maintain thorough documentation of quality and regulatory efforts, producing accurate records for communication, reporting, and potential dispute resolution.

People Management

● Serve as a subject matter expert and critical interface for quality and regulatory matters, fostering a culture of compliance, culture of food safety, and customer-centricity across teams.

● Collaborate effectively with cross-functional teams, promoting a collaborative work environment that prioritizes knowledge exchange and skill enhancement.

● Share expertise through mentorship and peer learning, contributing to the growth of the team's collective knowledge in quality, food safety, and regulatory management.

Key Priorities in the Next 6-12 Months

• Quality Management Implementation

● Develop and embed a robust food safety and quality management system, ensuring company-wide adoption and alignment with the value of quality-driven approaches.

2. Regulatory Adherence Framework

● Establish a regulatory compliance framework to guide Cauldron in adhering to industry standards and legal requirements.

• Strategic Project Management

● Provide project management expertise for critical impact projects across the business, enhancing operational efficiency and effectiveness.

● Comprehensive Compliance Dashboard

● Create a dashboard to monitor and report on food safety and quality metrics, regulatory compliance, and customer satisfaction, facilitating informed decision-making.

4. Continuous Improvement

● Drive initiatives to improve quality systems, efficiency, and compliance across our biomanufacturing operations.

5. Risk Management

● Identify and mitigate potential quality risks throughout biomanufacturing processes.

6.External Stakeholder Relationships

● Collaborate with the R&D Plant Manager and CTO to foster strong connections with external stakeholders, contributing to Cauldron's industry leadership.

Candidate Profile

● 5+ years of Food Safety and Quality Management Expertise: Profound knowledge of food safety and quality management principles and experience in implementing quality processes within regulated industries.

● Regulatory Compliance: Demonstrated understanding of regulatory requirements and the ability to translate them into actionable strategies. Proven experience in managing regulatory submissions and agency interactions.

● Strategic Mindset: Capable of aligning operational efforts with broader business strategies, prioritizing tasks effectively.

● Effective Communicator: Excellent communication skills, capable of crafting messages for both internal and external audiences, including senior stakeholders.

● Cross-Functional Collaboration: Proven ability to collaborate across diverse teams, fostering unity and achieving shared goals.

● Customer-Centric Approach: Passion for enhancing customer experiences while ensuring compliance and quality in all interactions.

● Organisational Leadership: Champion Cauldron's culture and values, promoting a cohesive work environment.

Prior experience with one or more of the following is essential:

● Office of the Gene Technology (OGTR) Requirements

● FSSC22000 or ISO 22000

● ISO 9001 and related standards

● Therapeutic Goods Administration (TGA) or U.S. Food and Drug Administration (FDA)

● Knowledge and experience with European regulations such as EFSA and REACH is a bonus

In this role, you will play a pivotal role in ensuring Cauldron's operations align with regulatory requirements and deliver outstanding customer experiences. Your blend of hands-on approach with a strategic mindset, attention to detail, and commitment to quality will drive our success in an evolving industry landscape.

It is essential that the Quality & Regulatory Manager will be based in Orange, NSW.

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