Head of Quality

3 weeks ago

City of Knox, Australia Medical Developments International (MDI) Full time

Direct message the job poster from Medical Developments International (MDI)

Medical Developments International (MDI) is one of Australia's leading specialised pharmaceutical companies with an industry-leading range of products in areas of pain and respiratory. Most notably, our lead pain relief product, Penthrox, is widely known here in Australia and is sold throughout the world.

At MDI, everything we do is guided by our core values:Safety First, Customer Focused, One Team, Performance Driven, and Accountability. These principles shape how we work together, serve our customers, and achieve outstanding results.

We are driven to continuously innovate and create meaningful value in all we do to improve patient experience and outcomes. We value the uniqueness and diversity of our employees and recognise that nurturing the diverse perspectives and strengths of our people translates into better patient care.

About the Role

The Head of Quality reports directly to the CEO and is a member of the Leadership Team. This position has overall accountability for all aspects of product, process and systems quality at MDI. This includes but is not limited to responsibility for the effective leadership of all Quality staff, and as the principal point of contact for all quality matters with external stakeholders, including government, partners, regulators and customers.

As the Head of Quality you will be responsible for oversight of the API manufacturing process, formulation, filling and secondary packing of the Penthrox drug. In addition, you will have oversight of the design/development, manufacturing (through 3rd party manufacturers) and release of a range of respiratory medical devices. This is a unique opportunity to lead a RX and Medical Device Quality team.

Your key responsibilities will be but are not limited to:

Quality and Compliance Management

  • Serve as the Management Representative for Quality, ensuring GMP, ISO 13485, and relevant regulations are met. Design, implement, and maintain the QMS for compliance with industry standards.
  • Report on QMS performance to executive management, highlighting areas for improvement and ensuring awareness of regulatory requirements across the business.
  • Act as the Authorised Person for Release for Supply, ensuring products (Drug Substance, Drug Product, Finished Product) meet local/international laws and GMP. Approve/reject materials for GMP compliance.
  • Ensure sourcing of approved raw materials and components from qualified suppliers, verifying that all goods meet required quality standards.
  • Represent the company in certification, customer, or quality audits for both pharmaceutical and device aspects. Address non-conformances and implement audits.
  • Maintain quality systems per FDA (21 CFR 820) and GMP guidelines.

Validation, Testing, and Auditing Oversight

  • Oversee validation activities (DQ, IQ, OQ, PQ), risk assessments, and protocols, ensuring equipment and premises meet GMP and QMS standards.
  • Approve test specifications, sampling instructions, and test methods. Oversee testing (raw materials, in-process, finished products) and review results for compliance.
  • Approve or reject materials, products, and production records, ensuring compliance with GMP. Investigate and resolve errors in production records.
  • Monitor contracted staff and ensure third-party services/products comply with GMP standards.
  • Oversee equipment installation, maintenance, calibration, and ensure systems remain validated.
  • Ensure batch manufacture complies with approved methods, GMP, QMS, and regulatory standards.

Leadership and Process Optimization

  • Lead and mentor the Quality team, ensuring proper training and resources for established procedures. Foster continuous improvement in quality and business objectives.
  • Drive initiatives to improve operational efficiency and profitability while prioritizing quality. Implement process improvements to reduce waste and increase efficiency.
  • Lead or participate in change management, including corporate strategic plans. Standardize measures to enhance transparency, results visibility, and collaboration.
  • Collaborate cross-functionally to align quality and operational goals, engaging in problem-solving to improve the quality management strategy.

About You

You are strategic, with a strong focus on quality and compliance. With a proactive approach and exceptional analytical skills, you'll drive continuous improvement across MDI's quality systems, ensuring full regulatory adherence. Your ability to lead teams and optimize processes will enhance operational efficiency while maintaining the highest standards. As a trusted authority in quality assurance, you'll balance technical expertise with leadership, empowering teams to meet MDI's goals and uphold product integrity. You also possess the ability and appetite to be an enterprise leader, contributing to discussions and offering viewpoints on all facets of our business.

It is essential that you have:

  • Experience in the pharmaceutical and medical devices area in GMP manufacturing compliance.
  • Familiarity with global regulators and ideally deep experience in an export led business.
  • Proven experience in leading regulatory inspections.
  • Demonstrated written abilities to produce KPIs, reports, policies and procedures.
  • Proven ability to motivate and lead a team of managers and staff to manage quality services.
  • A Degree in Science, Computer Science, Pharmacy, Engineering or equivalent.
  • An additional business qualification would be considered an advantage.
  • At least 5 years in a senior Quality Management role.

What do we offer?

At MDI, we will offer you:

  • a competitive salary and short-term incentives that reflects your skills and experience
  • opportunities for professional development and growth
  • a friendly and supportive team environment
  • MDI Anniversary Leave - 1 extra day off to celebrate your time with us

For this exciting opportunity, apply now

Seniority level
  • Executive
Employment type
  • Full-time
Job function
  • Quality Assurance
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr

  • GP Role at Head Medical

    5 days ago

    City of Wyndham, Australia Head Medical Full time

    Head Medical's clinic offers a unique blend of traditional and modern healthcare practices. Our team of experienced GPs and allied health professionals work collaboratively to provide comprehensive care to patients, with a strong emphasis on prevention and early intervention.A key aspect of our approach is the integration of allied health services, including...

  • Head Medical Professional

    1 week ago

    Shoalhaven City Council, Australia Head Medical Full time

    Key ResponsibilitiesAs a Consultant Psychiatrist with Head Medical, your primary purpose will be to provide high-quality specialist psychiatry services to emergency patients, inpatients, and out-patients at the relevant Hospital. You will support the development of psychiatry services and support and develop mental health research within the department.

  • Director of Quality Assurance

    1 week ago

    City of Knox, Australia Medical Developments International (MDI) Full time

    Medical Developments International (MDI) is a leading pharmaceutical company with a focus on pain relief and respiratory products. The company's product, Penthrox, is widely known in Australia and sold globally.MDI values its employees and recognizes the importance of diversity and inclusion in the workplace. As a quality professional, you will be part of a...

  • Senior Director of Quality Management

    1 week ago

    City of Knox, Australia Medical Developments International (MDI) Full time

    Our mission at Medical Developments International (MDI) is to make a meaningful contribution to the lives of patients through the development and delivery of innovative pharmaceutical and medical device solutions.We are seeking an experienced Quality Professional to join our team as the Head of Quality, who shares our commitment to quality and compliance. As...

  • Pharmaceutical and Medical Devices Quality Expert

    1 week ago

    City of Knox, Australia Medical Developments International (MDI) Full time

    We are seeking an experienced Quality Professional to join our team as the Head of Quality. The successful candidate will have a strong focus on quality and compliance, with experience in GMP manufacturing compliance and regulatory inspections.As the Head of Quality, you will oversee the API manufacturing process, formulation, filling, and secondary packing...

  • Head of Regulatory Compliance

    1 week ago

    City of Knox, Australia Medical Developments International (MDI) Full time

    Making a meaningful contribution to the lives of patients is at the heart of everything we do. As the Head of Quality, you will play a vital role in ensuring the quality and integrity of our products, from development to delivery.You will oversee the design/development, manufacturing, and release of respiratory medical devices, as well as API manufacturing,...

  • Head Of Risk And Quality

    3 weeks ago

    City Of Monash, Australia Predictus Search Full time

    Head of Risk and Quality Melbourne, Victoria Australian Clinical Labs(ASX: ACL - Clinical Labs) is committed to be the pathology provider of choice.Their business is growing rapidly and now has over 5000 employees and a truly national reach.They have approximately 100 NATA accredited laboratories that perform close to 9 million episodes each year for...

  • Head of Risk and Quality

    3 weeks ago

    City of Monash, Australia Predictus Search Full time

    Head of Risk and Quality Melbourne, VictoriaAustralian Clinical Labs(ASX:ACL - Clinical Labs) is committed to be the pathology provider of choice. Their business is growing rapidly and now has over 5000 employees and a truly national reach. They have approximately 100 NATA accredited laboratories that perform close to 9 million episodes each year for...

  • Medical Professional Sought for General Practice Position in Brisbane

    4 days ago

    City of Moreton Bay, Australia Head Medical Full time

    About UsHead Medical is a leading provider of medical services, dedicated to delivering high-quality patient care. Our team of experienced professionals is committed to making a positive impact on the health and wellbeing of our community.The RoleWe are seeking a motivated and skilled General Practitioner to join our growing team in Brisbane.This is an...

  • Medical Professional Opportunity

    5 days ago

    City of Wyndham, Australia Head Medical Full time

    At Head Medical, we are committed to delivering high-quality medical care to our patients. Our mixed medical clinic in Melbourne's surrounds offers a supportive environment for GPs and allied health professionals to work together, sharing their expertise to provide the best possible outcomes.The team is focused on preventive care, encouraging patients to...

  • Primary Care Physician Opening

    5 days ago

    City of Wyndham, Australia Head Medical Full time

    Head Medical's clinic is dedicated to delivering high-quality, patient-centered care in a supportive environment. Our team of experienced GPs and allied health professionals works collaboratively to address the complex needs of our patients, with a strong focus on preventive care and early intervention.On-site services include pathology, podiatry, diabetes...

  • Diverse General Practitioner Position

    5 days ago

    City of Wyndham, Australia Head Medical Full time

    As a General Practitioner at Head Medical, you will be part of a diverse and dynamic team dedicated to delivering exceptional patient care. Our clinic is located in Melbourne's outskirts, offering a peaceful and supportive environment that fosters collaboration and professional growth.Our team is passionate about preventive care, recognizing the importance...

  • Personal Assistant to the Head of Secondary

    4 weeks ago

    City of Knox, Australia St George Christian School Full time

    Waverley Christian College is a forward-thinking and culturally diverse Christian co-educational school from Kinder to Year 12. We have been providing students with a quality Christian educational experience for over 45 years. With campuses in Wantirna South and Narre Warren South, Waverley Christian College has an enrolment of over 2400 students with 400...

  • Personal Assistant To The Head Of Secondary

    1 week ago

    Knox, Australia St George Christian School Full time

    Waverley Christian College is a forward-thinking and culturally diverse Christian co-educational school from Kinder to Year 12.We have been providing students with a quality Christian educational experience for over 45 years.With campuses in Wantirna South and Narre Warren South, Waverley Christian College has an enrolment of over 2400 students with 400...

  • General Practitioner Required for Thriving Medical Practice in Queensland

    4 days ago

    City of Moreton Bay, Australia Head Medical Full time

    About the OpportunityHead Medical is seeking a skilled and motivated General Practitioner to join our team in Brisbane. As a key member of our practice, you will play a vital role in delivering high-quality patient care and contributing to the success of our business.The Job RequirementsProven experience as a General Practitioner, with a strong focus on...

  • Full-Time GP Wanted for Well-Established Practice in Brisbane

    4 days ago

    City of Moreton Bay, Australia Head Medical Full time

    Job DetailsHead Medical is currently seeking a General Practitioner to join our team in Brisbane. As a key member of our practice, you will be responsible for providing high-quality primary healthcare services to our patients. This is an exciting opportunity to be part of a well-established practice with a strong reputation in the local area.Key...

  • Psychiatry Consultant

    1 week ago

    Shoalhaven City Council, Australia Head Medical Full time

    Role SummaryThis exciting opportunity exists for a talented Consultant Psychiatrist to join our dynamic team at Head Medical. As a key member of our community mental health service, you will be responsible for providing high-quality diagnostic and consultative specialty services in inpatient or community psychiatry.

  • Head of Quality Assurance

    1 week ago

    City of Salisbury, Australia Dukosi Ltd Full time

    Main ResponsibilitiesQuality Management Strategy: Develop and implement a comprehensive quality management strategy that aligns with the company's business goals and objectives.Quality Systems and Processes: Oversee the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with industry standards.Leadership...

  • GP Opportunity Available at New Medical Centre in Brisbane

    4 days ago

    City of Moreton Bay, Australia Head Medical Full time

    Opportunity OverviewHead Medical is seeking a skilled and enthusiastic General Practitioner to join our team in Brisbane. As a key member of our practice, you will play a vital role in delivering high-quality patient care and contributing to the success of our business.The Job DescriptionProvide comprehensive primary healthcare services to our patients,...

  • Executive Head Chef

    21 hours ago

    City of Armadale, Australia Tmgwa Full time

    At Tmgwa, we are seeking an exceptional Executive Head Chef to lead our culinary team at the CY Precinct in Piara Waters.The successful candidate will have a passion for food and hospitality, with a proven track record of delivering high-quality dishes in a fast-paced environment.Key Responsibilities:Support the Head and Sous Chef in the day-to-day...