Quality Assurance

Quality Assurance & Compliance Manager - Melbourne office based
Overview

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.

Responsibilities

• Lead and facilitate local activities in order to enhance quality in project delivery.
• Works across all BUs in identifying, analyzing, and rectifying systemic quality issues in clinical delivery that are country specific in origin.
• Provides guidance and hands-on support to project teams for CAPA development and tracking.
• Monitor available KPI/Metrics reports across the BUs and identify common tendency/issues for quality improvement at a local level.
• Supports project teams in communicating and managing complex quality issues with the sponsor and/or with sites. Mentor the junior staff members if applicable.
• Engages in identifying the country specific training needs across the BUs and works with global and local stakeholders to provide required solutions.
• Collaborate with global stakeholders in quality related initiatives and activities in order to enhance quality in project delivery at a local level while maintaining compliance with global process.
• Designs and initiates audit/inspection-readiness assessment and improvement plan across all projects, collaborate with global/regional process owners to implements enduring solutions (into training, SOPs/WIs, clinical processes, Trusted Process, etc.) to ensure continuous audit/inspection readiness.
• Works 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.

Summary

Drive the quality improvement initiatives of clinical operations aiming at achieving the optimized cross-functional solutions on country specific matters.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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