Operational Services Manager, Compliance

3 weeks ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
An exciting opportunity exists for an Operational Services Manager, Compliance Filling to join our Operational Services team. Reporting to the Senior Manager, Operational Services Filling and based at our Broadmeadows Facility, you will ensure that all Operational Services support quality, schedule and cost adherence for the relevant manufacturing unit while ensuring the Manufacturing Business Unit and Operational Services work in partnership effectively.

**The Role**:

- Lead the team in collaborating with cross-functional departments to facilitate and conduct thorough investigations into incidents, non-conformances and deviations from standard procedures and identifying effective corrective and preventative actions.
- Support Manufacturing Leaders by providing guidance, support, and advice to address related to Deviations, CAPA’s, Training and other aspects of Operational Services within agreed governance and processes.
- Ensure the team, in partnership with Quality Assurance, appropriately classify deviation investigations that are simple/minor and complex in nature based on risk. Provide support for SQuIPP meetings, root cause analysis and agreement of robust CAPAs and analysis of repeat issues.
- Assist in completion of investigations inclusive of peer review across Operational Services Value streams as required to reduce risk and improve quality over time and ensuring manufacturing direct teams can meet the S & O plan.
- Responsible for managing the selection, performance and ongoing development of people within their team as well as developing succession, retention and development plans for key talent.
- Coordinate relevant governance and decision-making processes to align focus with strategy and the whole manufacturing value stream.

**Your skills and experience**:

- Tertiary Qualification in Science, Engineering, Biotechnology, Biological Sciences, or Pharmaceutical Science
- A minimum of 5 years’ managerial operations experience (R&D, Tech Services, Quality or Manufacturing) in a pharmaceutical, biotechnology, or biological industry
- Demonstrated understanding of cGMP, regulatory requirements and relevant environmental, health and safety requirements as applicable to secondary manufacturing
- Knowledge of validation technology, production and management processes within and external to the pharmaceutical industry

**How to apply**

**Applications close 5pm AEST on 11th August 2023**

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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