Quality and Compliance Manager

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Quality and Compliance Manager is a position within the Clinical Compliance Operations (CCO) responsible for supporting the Global Quality Operations Lead to provide therapeutically aligned compliance support to study teams focusing on clinical risk management, quality and compliance advice, adherence to procedural/regulatory requirements and CAPA resolution to ensure inspection readiness.

RESPONSIBILITIES AND ACCOUNTABILITIES

1

• Provide compliance support, including quality and compliance advice/consultation, to assigned study programs including maintenance of risk management to ensure adherence with procedural / regulatory requirements and driving inspection readiness.

2

• Manage Inspection Readiness activities for assigned programs and collaborate with Clinical QA to prepare internal and external staff. Support Clinical QA during the regulatory inspection process to provide expertise regarding the Clinical Development quality management system..

3

• Oversee and assist in the quality control (QC) consistency checks of critical clinical documents to ensure compliance with ICH-GCP, internal policies/procedures, templates and formats required for regulatory filing and optimal clinical program/trial delivery.

4

• Assist with Corrective and Preventative Actions (CAPAs) follow-up to ensure issues/deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner.

5

• Support the CCO Head in reporting metrics, identifying trends, and evaluating the effectiveness of completed CAPAs to drive continuous improvement.

6

• Support the development of procedural documents (SOPs) to ensure regulatory compliance and consistency across Clinical Development.

7

• Collaborate with the Process Improvement group to drive continuous improvement initiatives identified through CAPA, internal compliance monitoring and industry best practices/trends.

Education

• Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial experience.

Experience

• Extensive understanding of the clinical research and drug development lifecycle
• 5-7+ years of professional work experience in a Clinical Development/Research environment
• Experience in a management role is desirable.
• Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.

Competencies

The candidate must possess and have demonstrated the following skills:

• Extensive experience of working in a global pharmaceutical environment
• Experience of working in a Quality related and/or Process Management related environment /role
• Strategic development and analytical skills
• Experience in managing processes with a continuous improvement approach
• Strong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skills
• Demonstrated ability to navigate and negotiate competing priorities in a challenging environment
• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
• Proven experience in resource and budget management
• Ability to work and collaborate at all levels within an organization.
• Excellent communication and training skills, including English language skills
• Excellent organizational and time management skills
• Attention to detail
• Ability to work independently and as a team member
• Planning & co-ordination skills
• Diplomacy skills