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 Opportunity

We are seeking a Project Manager to join our dynamic team in our Global Quality Systems and Compliance function in Parkville (Australia). This role is a full time 12 month fixed position and the focus of the role is to support the business as part of the Regulatory Inspection responses and tracking of commitments, deliverables and focus on improving quality and compliance with cGMP.

You will also be responsible for utilising business and project management expertise to deliver major cross functional strategic projects related to the Regulatory inspection and in line with business plan objectives and timelines.

The Role

Reporting to the Director, Auditing/Inspections and Supplier Management, your responsibilities include:

• Lead multiple regulatory responses to support the development and implementation of one or more elements in collaboration with Quality, Operations, Engineering, Validation, Quality Control, Supply Chain, IT and Regulatory Affairs
• Lead cross functional teams to help optimise value, time, resources and risks, providing clear direction to required improvements, commitments and responses as necessary
• Develop and maintain integrated project plans and monitor project activities for adherence to milestones, timeliness deliverables against approved timelines and commitments.
• Develop and track relevant project KPI's and communicate project progress, risks and issues to relevant stakeholders
• Prepare presentations, reports and provide updates to stakeholders and at relevant governance meetings
• Provide guidance, support and mentorship to colleagues and acts as an advisor to projects teams

Skills and Experience

The successful candidate must have:

• Bachelor's degree in science or engineering related discipline
• Minimum of 10 years of experience in regulated industry, biotech/pharmaceutical industries preferred
• Experience authoring technical documents. Able to critically interpret results and generate technical conclusions consistent with Quality Risk principles
• Experience in planning, organizing and executing effective processes and projects
• Experience authoring reports, investigations and risk assessments
• In-depth knowledge of regulatory requirements and guidelines in particular PIC/s and FDA regulatory requirements to effectively deliver on project requirements, especially TGA, FDA and EMEA requirements
• Analytical and demonstrated problem solving skills
• Excellent verbal and written communication skills

How to apply

If this sounds like you and you are looking to further develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-123338.

Applications will close 5pm AEST on 13th October 2020.

CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.

Important notice to Employment businesses/ Agencies

Seqirus does not accept unsolicited referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Seqirus' Talent Acquisition to obtain prior written authorization before referring any candidates to Seqirus. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Seqirus. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Seqirus. Seqirus shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.