Job Title

QA Systems & Compliance Lead Apply for the QA Systems & Compliance Lead role at Opella. Opella is the selfcare challenger with the purest and thirdlargest portfolio in the OverTheCounter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health into peoples hands by making selfcare as simple as it should be for over half a billion consumers worldwide. At the core of this mission is our 100+ loved brands, 11,000strong global team, 13 bestinclass manufacturing sites and four specialized science and innovation development centres. Headquartered in France, Opella is the proud maker of many of the worlds most loved brands, including Natures Own, Cenovis, Ostelin, Telfast, Buscopan and Bisolvon. B Corp certified in multiple markets, we are active players in the journey towards a healthier people and planet. Find out more about our mission at www.opella.com. Job type: FixedTerm Contract - 24 months Location: Virginia, Brisbane About the Job Providing leadership and strategic direction, the QA Systems & Compliance Lead will shape processes, operating model and culture as Opella builds for the future. The QA Systems & Compliance Lead reports directly to the Site Quality Head and Project Portfolio Management (PPM) Lead and is responsible for all Quality Assurance and Validation activities for all site projects, including the introduction of existing and new product developments (EPD and NDP). Products manufactured in the Virginia site comprise both listed and registered complementary medicines and a growth view for the manufacture of OTC products, with distribution locally in Australia and within the Asia Pacific region. Main Responsibilities Development of validation protocols, execution and reports. Completion of all actions necessary for the NPD (as required), validation or assessments; update of validation matrix. Update the stability programme for NPD to assure ongoing stability testing. Review and approval of change controls and ensure impact assessments are completed. Provide technical input in the technical transfer and scaleup process from DC to M&S. Support development and provide guidance on manufacturing instructions, master formulations and bills of materials. Manage deviations (commercial batches or trials) required to assess proposed change prior to CC. Support DC in formulation development. Evaluate raw materials for EPD/NPD. Involve in the VISTA label creation process. Education University degree in Engineering, Pharmacy or a sciencerelated discipline. Experience Minimum 12 years experience in a cGMPregulated environment, ideally with TGA or PIC/s requirements knowledge and experience (fastmoving consumer healthcare, food or pharmaceutical industry background preferred). Minimum 3 years leading teams/supervisory experience; proven ability to lead teams in validation, stability or quality assurance. Sound understanding of cleaning validation, process validation, stability, equipment qualification and facility and utility qualification. Demonstrated and successful track record in technology transfer activities that resulted in a 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; ability to set and action priorities to meet objectives. Highly collaborative and 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 selfdevelopment. Demonstrated good work ethic and attitude. Technical Skills Technically minded with an ability to investigate manufacturing issues and root cause analysis. 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. Ability to achieve project objectives within tight timeframes and to perform in a highpressure environment. Why Opella At Opella, you will enjoy challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We are challengers, dedicated to making selfcare as simple as it should be, and we live our values: All In Together, Courageous, OutcomeObsessed and Radically Simple. Referrals increase your chances of interviewing at Opella by 2x. #J-18808-Ljbffr