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Form of workNational Compliance Manager
- Established national business with diverse portfolio of products
- Competitive remuneration package plus superannuation
- Interviewing now
About the company
This diversified business is a successful TGA / GMP licensed Pharmaceuticals Company who is well cemented in the Australian and Global markets. The business compounds and dispenses the latest imaging and therapy agents from manufacturer's worldwide for use in Radiopharmacies, Oncology, PET Imaging and Medical Imaging Centre and also provides specialist manufacturing services.
Culture
You will be working with a collaborative team of professionals based at the Sydney office. The business has an inviting, open communication mindset and fosters an atmosphere of new ideas, innovation and continuous improvement. The start/finish times are flexible for the right candidate.
What you will get in return
- Full time role
- Career development opportunities
- Flexibility / Work life balance
- Remuneration commensurate with experience
- Supportive senior and executive management
- Team building activities/social events
About the opportunity
The organisation is seeking a Compliance Manager who is keen to work on national projects and collaborate with the wider validation team on key daily tasks.
This is an exciting opportunity to coordinate the execution of GMP activities across the wider business to ensure compliance with regulatory requirements.
In this role you will managing all of the quality and compliance team by under taking daily required tasks and being involved in national projects.
This role is based in Sydney, and an attractive salary package will be on offer for the successful candidate. GMS Induction, Support and Training will be provided
Specific Duties
Quality Assurance and Compliance
• Serve as a trusted business partner in the all Quality Assurance space, who is proactive in your approach in addressing quality issues
• Manage the Quality Assurance team in meeting business needs.
• Implement and maintain the Quality Management system in compliance to PIC/s for applicable divisions.
• Manage the internal audit program and facilitate external audits.
• Establish a risk management program associated with the elements of the quality system.
• Ensure the QMS is deployed consistently nationally.
• Coordinate regulatory audits.
• Champion continuous improvement opportunities within the quality management system.
Validation
• Manage and lead the Validation Team in meeting business needs
• Establish, schedule and manage validation programs and projects
• Maintain documentation and archive systems for compliance, risk assessment and change control in coordination with the quality team
• Coordinate and guide the Operations and IT Teams as well as external contractors regarding validation requirements
• Assist GMP compliance and maintenance of QMS
• Support Quality related protocols, processes and reports
Regulatory
• Manage and lead the Regulatory Affairs Team in meeting business needs
• Act as a technical expert on regulatory and cross functional projects
• Be responsible for all Australia wide product safety and stewardship activities
• Identify and undertake process improvements and best practice initiatives
• Ensure full compliance with all applicable regulatory and corporate standards
• Overview the product registrations or exemptions
What you will need to succeed
• Minimum of 3-5 years’ experience in a similar role
• Good general knowledge of both pharma and TGA regulations
• Relevant Tertiary education (Science or Engineering degree or equivalent)
• Proven experience with in regulatory, quality assurance, validation
• Proven experience on improvement projects within quality systems implementation
• Team leadership capability and strong communicator
• Adapts quickly
• Well-honed management skills
• Dynamic management style
• Pharmaceutical industry experience highly desirable
• Innovative approach to problem solving
• Ability to promote business strategies whilst maintaining overall compliance with regulatory requirements.
Desired Skills
- Demonstrated experience with matrix, multi site team structure
- Experience within C level management team
How to apply
Click on the "Apply Now" button with a cover letter addressing the skills and experience above and a detailed resume.
