Quality Assurance Manager

**Quality Assurance Manager - location flexible**

**Who are we?**
We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**The role**
In addition to leading an experienced QA team the Quality Assurance (QA) Manager is responsible for contributing to the development, implementation and maintenance of the quality assurance program, line management, and the continuous improvement of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practice (GCP) and other applicable local and international regulations.

**Responsibilities**
- Develop, implement and maintain quality assurance and quality improvement systems to ensure compliance with GCP requirements.
- Work with DQA on department utilization and budget.
- Provide training and guidance to QA team in relation to the conduct of GCP audits.
- Provide guidance to other Avance departments on questions sent to QA.
- Oversee the planning, conduct, reporting and closure of study audits to ensure that studies are conducted in compliance with applicable regulatory and organisational procedures, including:

- o Auditing of Trial Master Files
- o Auditing of Study Databases
- o Auditing of Clinical Study Reports
- o Auditing of Investigator Sites
- Facilitate and provide supervision internal facility, process and vendor audits.
- Act as Audit Coordinator and host/ co-host 3rd party audits and inspections.
- Perform root cause analyses, investigation of quality issues and work as a CAPA facilitator.
- Coordinate the preparation, review and issue of controlled documents to support and maintain Avance Clinical's quality systems.
- Maintain an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas.
- Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

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**Qualifications, Skills and Experience**
- Bachelor's degree (preferably in a science field) or equivalent experience.
- Minimum 8 years' experience as a Senior Quality Assurance professional in the pharmaceutical / CRO industry operating in a GCP environment.
- Experience leading / managing a team.
- Experience in conducting Trial Master File audits, Database audits, Clinical Study Report audits and investigator site audits.
- Knowledge of local and international regulatory guidance related to the conduct and reporting of clinical trials.
- Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time with a high degree of accuracy.
- Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Demonstrated ability to take initiative in problem solving and in exercising judgment.
- Demonstrated ability to work harmoniously and cooperatively with other people and to work independently without supervision.
- Excellent time management skills
- Demonstrated ability to communicate effectively with clients, senior management and other departments.
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to work in, and be supportive of, a positive and dynamic team culture.
- Intermediate to advanced skills in MS Office suite.

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday

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**What next?**
As a growing business we're looking for likeminded people to join us - we hope that's you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered
- At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality._

Quality Assurance / QA / GCP / CRO / Pharmaceutical