Opella · 15 hours ago
Country Quality Manager
Virginia
Full-time
Hybrid
Mid, Senior Level
4+ years expOpella is a self-care challenger with a significant portfolio in the Over-The-Counter and Vitamins, Minerals & Supplements market globally. The Country Quality Manager will be responsible for implementing and maintaining the Opella Quality System across the local Commercial organization in Australia and New Zealand, ensuring compliance with global quality standards and regulatory requirements.
Health CarePersonal HealthRetail
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
Qualification
Required
Degree qualified in relevant Science discipline
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)
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
Company
Opella
Opella is a consumer healthcare business segment of Sanofi.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-20Acquired
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