Role Title: Quality Assurance Compliance Lead
Location: Virginia, Brisbane
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.
Role Summary
An exciting and dynamic leadership role within the Site Quality Assurance team. By providing innovative leadership and strategic direction, this motivated person will be the owner of Quality Assurance across the organisation 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 Compliance Lead directly reports to the Site Quality Head. They are responsible for all Quality Assurance activities with a focus on the operational activities including deviation management, batch release and complaints management. 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 visible and cross-functional role with collaboration across production, engineering, supply chain and Quality Control. Stakeholder management is key and 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:
- Be responsible for the position of the Authorised Person for the market release of Virginia site manufactured product.
- Responsible for Deviation and Complaints Management for the Virginia site.
- Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.
- Review and approval of operational GMP documentation as needed.
- Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state.
- Production processes and areas are audit ready at all times
- Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review
- Quality behaviours exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP
- As Quality Assurance’s representative, be the first point of contact for any issue that may result in change to or deviation from a validated system or process that may impact product quality or safety.
- Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation.
- Proactively identify continuous improvement opportunities; potential risks; and cGMP deficiencies to processes and documentation. Work closely with Production and Engineering to implement appropriate improvement or corrective measures.
- Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times.
- The management of Product Technical Complaints and associated investigations
- Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies
- Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality.
- In conjunction with Area Management ensure that responsible areas are in a state of readiness for regulatory and customer audits with all information readily available.
- Perform the review/audit of batch records as per approved QA checklist.
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
This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.
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 , 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 .
