Senior Quality Management Position
In this senior leadership role, you will oversee and manage all quality and regulatory functions for the Melbourne site. Your primary responsibilities include ensuring an effective Pharmaceutical Quality System is in place, adequate resources are available, and roles, responsibilities, and authorities are defined and implemented.
The successful candidate will have a strong background in cGMP pharmaceutical manufacturing, with 10+ years of experience in a Quality Assurance or Quality Control leadership role. A Bachelor of Science in Pharmacy or related discipline is required, along with excellent written and verbal skills, good attention to detail, and documented cGMP training.
You will work closely with senior leaders and other stakeholders to ensure compliance with Good Manufacturing Practice (GMP), company Standard Operating Procedures (SOPs), and Health and Safety policies. This role requires exceptional communication and coaching skills, as well as the ability to influence and drive continuous improvements.
* Develop and implement a comprehensive Pharmaceutical Quality System that achieves quality objectives.
* Oversee the implementation and compliance of the Pharmaceutical Quality System at the Melbourne site.
* Establish and promote quality key performance indicators and ensure site awareness and action.
* Manage and approve/reject quality investigations related to deviations, customer complaints, and nonconformances.
* Engage with clients/sponsors and address client/sponsor queries to enable product information transfers and compliance with clinical trial protocols and regulatory requirements.
Key Working Relationships:
* Reports directly to the Senior Leadership Team.
* Collaborates closely with local and global internal and external stakeholders, including Project Management, Finance, Production, Warehouse, Human Resources, Engineering/Maintenance, and regulatory bodies.
Required Qualifications:
* Strong understanding of cGMP principles and regulatory requirements.
* Proven leadership experience in Quality Assurance or Quality Control, preferably in pharmaceutical manufacturing.
* Excellent communication and interpersonal skills.
* Ability to analyze complex problems and develop effective solutions.
Preferred Qualifications:
* Master's degree in a relevant field.
* Relevant industry certifications, such as CQPA or Certified Quality Manager.
* Experience working with Lean/Six Sigma methodologies.