Quality oversight of the activities for all departments within the assigned Value Stream. This includes operational quality oversight for the area and for the processes, to assure appropriate quality of the products manufactured with the value stream.

Responsibilities:

Overseeing adherence to any applicable CSL standards and procedures, via review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and monitoring and continuous improvement of quality performance metrics.Oversees all Quality related activities that support within the Value Stream to support the process.Partner with all teams within the value stream regarding product quality aspects.Responsible for support and oversight of manufacturing shop floor quality, shop floor hygiene/sterility assurance.Agency audit participation including assisting in the presentation of quality investigations and decisions to health authorities, leading tours, or acting as back room support or as a host.Maintains a current status for department GMP training requirements and provides oversight to onboarding training to department personnel.Accountable to manage all batch documentation review per unit operations and issue batch disposition recommendation within deviation investigations.Partners with the team to support/review/approval of trends, product technical complaints, investigations, corrective & preventative actions, and change control.Leads the respective teams to facilitate new ways of working to develop the desired culture within relevant quality areas.Foster a culture of continuous improvement, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.Responsible for representing Quality Assurance Operations on local and global projects and serving on steering committees as required. Collaborates and acts as liaison globally with other CSL sites regarding investigation resolution.Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.Reinforces safe working practices with team and champions the safety culture within the site team.Maintain a status for department training requirements and provide training to department personnel.Responsible for ensuring all deviation events are properly classified, investigated, and given correct final disposition. Responsible for ensuring proper Root Cause Analysis tools are used for investigations resulting in robust corrective and preventive actions. Responsible for review/approval of all high/substantial risk investigations. Oversee environmental investigations that are relative to routine monitoring and/or product monitoring. Responsible for contact with other CSL sites and Global communication regarding investigations and/or changes.Drive continuous improvement initiatives and provide quality oversight of change management activities.Assists in hosting regulatory agency inspections, as required by Quality Assurance Management.

Qualifications
Education:

University degree in relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)

Experience:

5+ years' GMP experience in pharmaceutical/biotech/or other regulated industryExperience within a global matrix organizationKnowledge of current Good Manufacturing Practices (cGMP) principlesKnowledge of appropriate regulatory requirements

The expected base salary range for this position at hiring is $96,000 - $115,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!