Job Description

• Hiring Manager Title: Dina El-Emary
• Location: Brisbane
• 1 day/week remote working
• Job type: Full Time, permanent

To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume.

About us

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Telfast, Nature’s Own, Cenovis & Ostelin we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.

We are also proud to have been the first, large, pure consumer healthcare company to achieve B Corp certification with Australia in February 2025. Today, with 2/3rd of our business certified, we continue to make progress towards global certification.

Join us on our mission. Health. In your hands.

An exciting and dynamic leadership role within ………… …By providing innovative leadership and strategic direction, this motivated person will …..

This role has true ownership of ………………………………………. across the organization with opportunities for regular senior management exposure. Beyond delivery of results this person will be able to shape processes, operating model and culture as Opella builds for the future.

Main Responsibilities

The Quality Assurance Systems and Technical Lead directly reports to the Site Quality Head and manages a team of Quality Assurance professionals. The Lead is responsible for all Quality Assurance Systems and Validation activities for the Virginia Manufacturing site. Products manufactured in the Virginia site comprise both of listed and registered complementary medicines and a growth view for the manufacture of Over The Counter (OTC) products, with distribution both locally in Australia and within the Asia Pacific region. This is a highly critical role within the site and also cross-functionally for the management of change controls, qualification, validation and third party management, the self-inspection program and external regulatory inspections, among other Quality management systems. This role will represent all quality systems and validation related activities for the site at the Quality Leadership level.

The Lead shall assist in the establishment and continuous development of a robust Quality System of an appropriate standard and shall lead a team of Quality professionals in one of the key areas of Quality Assurance, Validation & Technical Support. They will plan, organise and coordinate their team’s workload, so as to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Opella Healthcare. They will have responsibility to ensure that their QA Validation & Technical Support work stream meets Quality Key Performance Indicators, in line with Organisational and Regulatory Standards and will take part in Quality and Regulatory Audits.

The Lead shall participate in and lead their team in site wide Quality observations and Internal Audits with a key focus on continuous improvement and efficient compliance. The Lead shall facilitate the empowerment of their team members for operational quality decision making, without compromising the Quality System &/or Standards.

Main responsibilities and accountabilities include:

Quality Compliance

• Manage and assist in the processing of Non-Conformances, Process Deviations, Corrective & Preventative Actions, Compliance Issues, Deletions & Quality Observations and associated documentation and filing of both physical and electronic documents, in line with Organisational, Regulatory and Environmental Standards.
• Manage and Drive Change control activities related to Validation and Calibration of new equipment and processes.
• Assist in the creation of new documentation and review existing documentation associated with equipment and processes within the facility.

Validation

• Manage the Site Validation Master Plan as required to ensure current alignment to regulatory and organisational requirements.
• Manage validation related activities to ensure, in accordance with the principles of cGMP, that the processes, equipment, cleaning methods, facilities, services, computer systems, spreadsheets & procedures employed within the operational facility will be able to consistently manufacture Complementary Medicinal products which achieve the relevant product specifications, in accordance with regulatory standards and organisational requirements.
• Manage the planning & reporting of all Virginia site validation and calibration activities e.g. Validation and Calibration of Equipment, Facilities, Services, HVAC, Processes, Cleaning, Computerised Systems, Spreadsheets.

Calibration

• Manage the Calibration Register and Calibration activities across the site.
• Schedule External Contractors to conduct calibrations when required.

Technical Support

• Facilitate the cross-functional working relationships of the team by managing interactions between the team and key stakeholders including, External contractors, Operations, Engineering, Occupational Health & Safety, QC, ID&I and Regulatory Affairs.
• Assist in investigations, reviews, management and co-ordination of Quality Systems throughout the facility.
• Provide Technical advice and expertise with respect to Validation, Calibration and Quality Compliance.

Health, Safety and Environment: Cooperate with Management to:

• Provide and maintain systems of work, and working environments that are safe and without risks to health.
• Provide the information, instruction, training and supervision necessary to ensure the health and safety of employees.
• Consult with employees about OHS matters so that they can contribute to decisions affecting their health, safety and welfare.
• Ensure the health and safety of people visiting or working who are not employees by not exposing them to risk.
• Comply with corporate and legal health and safety requirements.
• Identify and correct unsafe conditions or behaviours and immediately notify the Manager of any serious incidents; complete and Incident / Injury Report and forward to People & Culture within 48 hours where necessary.
• Undertake duties in accordance with the current Opella Policies and Procedures.
• Report non-conformance in accordance with the requirements of the Opella quality system

About You

We believe that professionals with the following experience and skillsets are well-suited for this position:

Essential Skills & Experience

• Minimum 15 years’ experience in cGMP regulated environment, ideally with TGA or PIC/s requirements knowledge and experience.
• Min 3 years leading teams / supervisory experience, Proven ability to lead teams in validation, stability or quality assurance.
• Sound understanding cleaning validation, process validation, stability, equipment qualification and facility and utility qualification.
• Demonstrated and successful track record in successful technology transfer activities that resulted in commercial product.
• Ability to clearly and concisely express ideas in spoken and written communications.

Soft skills

• Strong ability to build and maintain relationships with internal/external stakeholders.
• Strong organisation, planning and critical thinking skills. Has the ability to set and action priorities to meet objectives.
• Highly collaborative and is able to influence and achieve results in a team environment.
• Ability to work independently and as part of a team.
• Demonstrated Leadership capabilities.
• A flexible and adaptable approach.
• A strong dedication to the job combined with a willingness for self-development.
• Demonstrated good work ethic and attitude.

Technical skills

• Technically minded, with an ability to investigate manufacturing issues and root cause analysis.
• Also have a good knowledge and understanding of GMP, GLP and GDP guidelines and regulations.
• Strong orientation for quality systems and methodologies to improve production outcomes. Understanding of manufacturing, quality control and quality assurance systems including
• Ability to achieve project objectives within tight timeframes and to perform in a high-pressure environment

Education University degree in Engineering, Pharmacy or a science related discipline