Overview
Quality Assurance & Compliance Manager- Melbourne office based
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Responsibilities
* Lead and facilitate local activities in order to enhance quality in project delivery.
* Work across all BUs in identifying, analyzing, and rectifying systemic quality issues in clinical delivery that are country specific in origin.
* Provide guidance and hands-on support to project teams for CAPA development and tracking.
* Monitor available KPI/Metrics reports across the BUs and identify common tendencies/issues for quality improvement at a local level.
* Support project teams in communicating and managing complex quality issues with the sponsor and/or with sites. Mentor the junior staff members if applicable.
* Identify country specific training needs across the BUs and work with global and local stakeholders to provide required solutions.
* Collaborate with global stakeholders in quality related initiatives and activities to enhance quality in project delivery at a local level while maintaining compliance with global process.
* Design and initiate audit/inspection-readiness assessment and improvement plans across all projects, collaborate with global/regional process owners to implement enduring solutions (training, SOPs/WIs, clinical processes, Trusted Process, etc.) to ensure continuous audit/inspection readiness.
* Work with regional Process Quality Management lead to engage in quality enhancement at a local level.
Qualifications
* BA/BS degree in science or healthcare, or equivalent combined education and experience.
* Moderate clinical research experience in Pharma/CRO/Site Management preferred.
* Knowledge of ICH GCP, JGCP or In-country equivalent required.
* Knowledge of basic project management required.
* Experience of project management in clinical operation preferred.
* Extensive leadership skills preferred. Ability to act independently and proactively on personnel management, customer management, and project management.
* Ability to perform several tasks simultaneously to meet aggressive deadlines.
We are always excited to connect with great talent. This posting is intended for an upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
About Syneos Health
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
#J-18808-Ljbffr