Quality Assurance

**Description**

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**

Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

**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.

Job 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._

**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.

**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. Occasionall