Development Quality Manager
* Location: Virginia, Brisbane
* Exposure to senior global stakeholders
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
About the job
The Development Quality Manager ispart of the Global Quality and Sciences team based at the Virginia, Brisbane site and responsible for leading and managing the implementation of the Opella Global Quality standards to create a state-of-the-art approach across the business. You are accountable for building the Quality System at the Virginia Development Centre, implementing new Ways of working for quality activities in this regulated, challenging and matrical environment.
Driving DC Quality to full compliance, and ensuring our OTC, Complimentary medicines, and Food Supplements products are the of the best standard for our consumers.
You are also responsible for enhancing and championing a Quality culture across the Development Center and cross-functionally, educating, and leading all Quality activities and continuous improvement initiatives.
Responsible for leading the liaison with M&S Site Quality, ensuring simplification and tailoring of DC quality processes as well as proper interaction for shared quality systems.
Main Responsibilities:
* Design, implement and manage quality systems in compliance with company standards and processes and according to DC specificities. This includes:
* Own the local Development Quality roadmap:
o Contribute to the setting of the yearly Global Development Quality Roadmap; Monitor local progress towards completion and report quarterly
o Manage Quality Documents (QD): Ensure an efficient QD system is in place in the Development Center:
o Secure process and QD compliance to the company standards; Be the final reviewer and final approver for procedures, documents, protocol, and reports in terms of quality (logbooks, calibration, maintenance, qualification, temperature & humidity, stability)
o Oversee Training management
o Manage training curriculum; Assign training as required
o Follow-up / deliver GMP training program
o Lead Audit & inspections (readiness, conduct and follow up) and manage self-inspection
* Organize the preparation for quality audits and inspections at DC;
* Welcome auditors/ inspectors, act as the interlocutor for DC
* Follow-up on audit and inspection
* Manage self-inspection (participate and/or lead as applicable).
* Oversee Development suppliers and third-party quality management
* Review qualification status
* Check related Quality documents
* Be the quality representative in projects
* Collaborate with the Head of Formulation and the Head of Analytical as the Quality expert to ensure high quality of products
* Manage related quality activities: events & CAPA, analytical validation, QRM, suppliers/third parties.
* Review and approve related documents: specification development report, specification, formula checking with restricted ingredient list.
* Lead quality continuous improvement and proactively grow quality in DC
* Lead or contribute to local and global initiatives
* Proactively and promptly deploy and apply in DC new, advanced and modern quality applications following the trend of digitalization
* Monitor and report quality KPI
* Prepare and Lead annual quality reviews
* Coordinate and secure Data integrity
* Be a trusted and transformational business partner to the Team in Virginia DC and with other local and global stakeholders
* Influence a quality driven development
* Support the team navigate quality in a context of project pressure
* Build the rationale from the rules to educate and convince teams
* As a member of Global Quality
* Provide reports of Development Quality highlights
* Report relevant information to prevent or revert quality crisis
* Manage special projects assigned by supervisor as relevant
* Participate to the quality meetings as a Development Quality representative
* Lead local quality culture events (incl promotion & visibility)
* Collaborate closely with other DC quality managers globally and with direct manager despite the time zone challenge
About you
Experience:
* Experience in R&D Quality Management and/or Development (ideally 5 years +), and Quality systems, in Consumer Healthcare or Pharmaceutical industry (Complementary Medicines preferred, OTC or Food supplements a bonus)
* Proven ability to effectively communicate and present to senior stakeholders, and collaborate with global teams
Technical & Soft skills:
* Ability to be the go-to Quality expert and Business Partner to the Development Center
* Open minded, active listener with negotiation and influencing skills are critical
* Strategic thinking, ability to step back and explain basic steps in a constructive manner
* Autonomous and flexible in your working hours to work with a highly global team
* High level of assertiveness and networking/collaboration capability
* Bring level of enthusiasm to create, reflect and educate a Quality culture
Languages:
* High level written and verbal English is compulsory (working language) - other languages welcomed
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.