Job summary

• Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards

• Supervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)

• Schedules and communicates with appropriate functional groups regarding status of activities and quality testing requirements

• Provides expert review of data, protocols and reports for adherence to cGMPs and good documentation practices

• Communicates aberrant results and leads investigation to determine root cause

• Ensures quality control training and reviews and approves standard operating procedures (SOPs)

• Coordinate and ensure that team objectives are achieved and operational decisions made and executed in a timely manner

• Provide technical leadership and to co-ordinate the activities of work allocated to the team of analysts; specifically, the testing of Quality Control samples and to support validation studies.

• Support and manage organisational change and process improvements through development and coaching of a team.  Maintain a presence within the laboratory area to monitor laboratory activities.

Principal accountabilities

• To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team, in accordance with current regulations and procedures guaranteeing that the area is permanently inspection ready. 

• To schedule the activities of the team, monitoring and approving holidays, sickness absence and training/competence position of all associates.  The monitoring of associated KPIs being used to adapt plans accordingly.

• To review and approve data generated from testing and to bring to the attention of the Team Manager and other site personnel test results and any trends, out of specification results.  In addition where appropriate perform the required transactions to release materials.

• To ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards.  To ensure the use only of approved and validated test processes.

• To co-ordinate department cGMP systems, such as deviation management, closure of corrective and preventative actions, change controls and SOPs.

• To participate in improvement project teams where required driving quality decisions and provide advice and technical support where required.  Coordinate completion of any resulting activities. To lead troubleshoot in the resolution of testing problems involving your team and relevant customers/suppliers.  Demonstrate creative problem solving within cGMP constraints and align with best practice.

• To track the team ensuring that mandatory training is in place.  To encourage optimal performance of staff through training, feedback every two months and development planning in conjunction with the Team Manager

Knowledge, skills and competencies

• Bachelor’s degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.)

• 5 years' quality control experience in the pharmaceutical/biotech/or other regulated industry

• cGMP background in the pharmaceutical industry

• Experience of Quality Control testing techniques and industry practices

• Proven time management skills for planning and schedule of work

• Proven Communication skills both written and verbal

• Leadership skills in supervision of teams

• Experience in test and equipment validation

• Knowledge of FDA and EMA requirements

• Knowledge of continuous improvement techniques and advanced root cause analysis techniques

• Fluency in English

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus