External Manufacturing Quality Manager- AU & ASEA

• Location: Brisbane

• Hybrid work environment (mostly remote)

About the job

Do you have Quality experience in Pharmaceutical Manufacturing and passion for building trusted business partnerships?  The External Manufacturing Quality Manager- AU & ASEA is responsible for the Quality and Compliance oversight of CMO’s in Australia and is vital in ensuring smooth coordination of third-party manufacturers and suppliers. This role will ensure all GxP requirements are held to local and global Opella Quality requirements and to foster best-in-class supplier relationships with our external partners.

At Opella, the Consumer Healthcare business unit of Sanofi, it is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.  

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. 

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Telfast, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

Join us on our mission. Health. In your hands.

Main responsibilities:

• Serve as the functional quality representative and ensure that CMOs / third party /suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are in compliance with international and local regulatory requirements, quality agreement, the registered dossier, and Opella global quality documents when applicable

• Participate in the Quality Due diligence, evaluation, selection, and approval of third-party manufacturers- Contract agreement and negotiation

• Contribute to the third-party audit plan for the ASEA & AU hub and request / allocate / perform the GxP audit per plan

• Regular monitoring, assessment of records and results related to the contracted GMP activities

• Quality Risk, Change Control Management, Safety Review, Deviation management and Product Recall processes

• Manage the review, discussion, and follow-up of CAPAs related to audit and to the ongoing management of products manufactured by the third-party for Sanofi

• Complaints management with review of complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend and initiating CAPA if / where required

• Contribute to business operation by establishing partnerships and establishing trust with the CMOs / third party /supplier business partners and providing quality oversight and support for quality operations activities

•  Communicate or escalate activities, issues, and progress to the Head of Quality EM AMEA

• Contribute to the establishment and continuous development of a robust Quality System of an appropriate standard and collaborate in the key areas of Quality Assurance as applicable with Quality Excellence team

• Plan, organise and coordinate workload to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Opella (previously Sanofi Consumer Healthcare) procedures

• Together with the regional team, ensure that the entity meets Quality Key Performance Indicators, in line with organisational and regulatory standards, and take part in Quality and Regulatory Audits (if applicable)

• Participate in the Quality observations and Self-inspection program for EM CHC AMEA with a key focus on continuous improvement and efficient compliance

• Collaborate with other Quality Managers / team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence of the Quality Documentation, Quality Systems Management and Quality Technical Support

• Support Training and perform Self inspections as required

• Manage electronic learning management system, personnel training curricular, and monitor execution for training needs

• Cross-functional engagement with key stakeholders with external contractors and internal functions

About you

Education:

• Degree in Pharmacy, Pharmaceutical Science or other related Science field

Experience:

• Ideally 8 x years working experience in Quality of Manufacturing in the Pharmaceutical or Consumer Healthcare Industry- Complimentary Medicine and VMS experience a bonus!

• Proven background managing external business partnerships with suppliers and manufacturers preferred

• Advanced knowledge of Good Manufacturing Processes for Australia and ASEA is a must - other country or regions an advantage

• Experience with Internal and External Auditing, CAPA, Risk Assessment, Troubleshooting, and Root cause analysis

• Ideally a background within a matrix organisation working with regional, remote teams and cross-functional collaboration at all levels

Technical & Soft Skills:

• Strong leadership skills including influencing, mentoring, coaching and motivation

• High level communication with excellent command of English (written and verbal)

• Ability to build trusted business partnerships and relationships with your impressive interpersonal skills

• Able to prioritise workload and leverage team for support

• Highly autonomous and self-driven to work with a remote team, and external contractors at multiple sites across Australia and ASEA

• Excellent collaboration and team-work

• Advanced reporting and tracking, Microsoft suite and Project Management tools

• Analytical thinking and problem solver!

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave for permanent employees

• Endless development opportunities and career trajectory, highly supportive team environment

• Join a global leading Healthcare organisation with consumer loved products and our very own home-grown Australian brands onsite!

• State of the art facilities in beautiful Brisbane, Queensland

• High performing and supportive team environment, where we encourage you to have work-life balance