QA Systems & Compliance Lead

• Job Title: QA Systems & Compliance Lead
• Hiring Manager Title: Quality Lead & PPM Lead
• Location: Brisbane
• 1 day/week remote working
• Job type: Permanent role

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an [Experienced Hire Role], you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human. 

Main Responsibilities                                               

The Quality Assurance Systems and Compliance Lead directly reports to the Site Quality Head and has a dotted line to the Project Portfolio Management (PPM) Lead.  They are responsible for all Quality Assurance and Validation activities for all site Projects and also the introduction of existing and new product developments (EPD and NDP).  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 collaborative and cross-functional role with key stakeholder management whilst assuring Quality in the areas of manufacturing, engineering, supply chain and Country Quality related to the establishment of new products or projects.    This role will represent all quality related activities for the site at the Quality Leadership level.

Main responsibilities and accountabilities include:

•       Development of Validation protocols, execution and reports.

•       Completion of all actions necessary for the NPD (as required), validation or assessments.  Update of validation matrix.

•       The update of the stability program for NPD to assure ongoing stability testing incorporating the new product and if grouping is appropriate, including all related documentation such as the stability matrix.

•       Review and approval of Change Controls and ensuring impact assessments are completed.

•       Providing technical input in the Technical Transfer and scale-up process from DC to M&S

•       Supporting development and providing guidance on the manufacturing instructions, master formulations and bills of materials

•       Management of deviations (commercial batches or trials) required to assess proposed change prior to CC

•       Support DC in formulation development

•       Evaluation of raw materials for EPD/NPD

•       Involvement in the VISTA label creation process

 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

About Us: 

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.   

Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. 

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane,Dulcolax, Enterogermina, Essentiale and Mucosolvan.  

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.