Head of Quality

Head of Quality (The position has been filled)

• Lead the Quality Assurance Strategy and Promote Growth
• Drive Continuous Improvement of the Manufacturing Facility
• Join a Great Team and Support Growing Business

 

CLIENT

Our client is a vibrant player in the Health and Complementary Medicine Industry servicing the Australian and global market place, based in Melbourne.

With a very clear purpose and vision, product pipeline and significant regulatory approvals, this company continues to grow and excel.

With recent investments in modern new facilities and an amazingly positive vibe throughout their various teams, the person in this role will lead the company’s Quality Assurance activities.

 

ROLE

Busy, Exciting, Varied and Well Supported!

Walking into our client’s new premises based in Melbourne you can’t help but get excited! The company is growing, the staff are busy and everyone is smiling. But it’s not all about work. The company cares about its staff and has introduced various activities to reward and support this amazing group of people.

We are looking for a Head of Quality that is energetic and passionate about their work, willing to learn and grow. You will thrive in a busy and supportive environment where people care and help each other to ensure common goals are met.

Excellent interpersonal and communication skills are paramount for this role as is the ability to work well within a team and autonomously as needed.

This role is located in our client’s manufacturing facility in one of Melbourne’s western suburbs.

RESPONSIBILITIES

We are looking for an experienced Head of Quality Manager with substantial prior knowledge in the management of a Quality Assurance Systems and Quality Assurance teams within the pharmaceutical or related industries.

Reporting directly to the Director of Operations, this important role will regularly interact with the highest levels of the company and collaborate with peers within the on-site management team.

Mentorship of the direct reports in the Quality Assurance Team, so as to develop their management skills, is to be expected from this leadership role.

This senior managerial position will have oversight of all Quality Assurance work including effective delivery of compliance framework, compliance programs, continuous improvements, internal and external audits of suppliers, stability programs and similar. Some other accountabilities Include:

Operational & Technical Contribution

Complete management and communication in regards to all Quality Assurance documents and procedures such as change controls and deviations. Manage communication with all stakeholders if any significant quality issues arise that may impact product quality or regulatory compliance.

Stakeholder management 

The person in this role will ensure efficient communication amongst the Regulatory & Quality teams and to all other appropriate functional areas as required. Communication with internal and external stakeholders is imperative in order to effectively drive continuous improvement and product compliance.

 

REQUIREMENTS

To be successful in your application you will have a ‘can-do attitude’, be collaborative in your approach and have a proven track record and ability to be a leader of a champion team.

A summary of the required criteria include:

• Relevant qualifications in Science with a bachelor’s degree as the minimum
• Proven track record of development and maintenance of the Quality Management System and maintenance Quality Systems  in line with TGA requirements

• Experience with development, review and approval of company SOPs and other controlled procedures
• Proven technical knowledge and understanding of product range
• Prior experience in developing and educating the business to follow a robust process to investigate quality issues that get to the root cause and then provides long-term solutions
• Involvement in the internal pharmacovigilance system
• Previous experience with raw material qualification and dossier development
• Hands-on experience with the specification reviews and specification development for new product development
• Many years of experience with approvals of technical and quality GMP agreements with different stakeholders
• Proven experience with management of quality aspects of Third-Party Manufacturers for all products manufactured externally
• Experience with handling  TGA or client-initiated recalls
• Ensure that all quality requirements are met and understood by key stakeholders in the business
• Work with Supply Chain for the approval of new materials, stability programs supporting and maximising shelf life
• Provide support and education for the review and investigation of customer complaints

 

APPLICATIONS

To discuss this excellent opportunity please call Jo on 03 9516 0100 or after hours on 0411 197 171.

To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

 

THANK YOU

Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.