Country Quality Manager (FTC)
* Location : Virginia, Brisbane
* 12 x month FTC opportunity
* Hybrid working- 3 x days onsite/ 2 x days WFH
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: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.
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 four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world's 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 healthier people and planet.
Find out more about our mission to bring health in your hands at www.opella.com.
About the role
The Country Quality Manager (FTC) will be responsible for the implementation and maintenance of the Opella Quality System (covering GxP and health-regulated activities) across the local Commercial organisation in Australia and New Zealand, to ensure that quality processes and activities in scope are executed in compliance with the Opella Global Quality standards and applicable GxP regulatory requirements.
Secure delivery of safe, efficient, quality products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.
This role works closely with the Science hub organization as well as with other Quality peers, colleagues from other global Quality operational units, M&S and Support Functions, and reports directly to the Country Quality Head.
Main Responsibilities
* Develops and implements the quality program in alignment with local and corporate objectives.
* Establishes effective working relationships across the local business, other affiliates, key customers and suppliers.
* Fosters a sense of quality throughout the business.
* Establishes and maintains quality across the Opella organisation. The system must be compliant with Opella global quality directives, local regulatory requirements and other quality systems as required such as ISO9001:2015.
* Manages product quality in accordance with GMP and company procedures.
* Fulfil role as Complaint Officer for ANZ who logs complaints received from the market, notifies relevant manufacturing sites, coordinates review and closure, and performs quarterly trending to make improvements
* Complete the Marketing Authorisation Holder review for APR/PQRs for all marketed products
* Develops and carries out an audit program for the detection, and rectification of anomalies within the quality system, in accordance with GxP principles, ISO and company procedures.
* Maintains an appropriate level of supervision of third-parties and service providers and mitigates any risk of non-conforming products.
* Releases products for distribution in conformance to the registered specification.
* Performs required qualification for transport routes for products marketed in Australia and New Zealand.
* Ensures an effective document management system is in place and works with others on the development of documentation.
* Provides leadership and assists in the management of critical quality events such as recalls.
* Participates in the use of Quality Management techniques in the improvement of company processes.
* Works with key customers and suppliers to improve processes.
* Provides support (as needed) to internal stakeholders (Supply Chain, Scientific Affairs) relating to manufacturing and quality.
* Ensures an effective learning management system is in place and provides training to the Commercial organisation on quality systems and processes, as required.
* Participates in projects as required
* The role holder should work in close collaboration with colleagues from Scientific Affairs, Pharmacovigilance, Supply Chain, and supports the CQH in managing other activities requested by the Opella Global Quality organisation.
* The role holder should have the knowledge to ensure GMP/GDP practice is adhered across the Opella Commercial organisation.
About you
Qualifications:
* Degree qualified in relevant Science discipline
Experience:
* Ideally min 4 x years experience in a similar ANZ Country Quality role within Pharmaceutical or Consumer Healthcare industry
* TGA experience is a must
* Strong knowledge of GxP (GMP experience also an advantage)
Skills and Attributes:
* Exceptional communication skills and engagement cross-functionally
* Ability to work autonomously, and decision making
* Strong compliance mindset
* Results driven and can-do attitude- Solution orientated!
* Change agent, resourceful and innovative
Why us?
At Opella, you will enjoy doing 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.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
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