You will be responsible for managing and directing Quality Control activities for the respective manufacturing site. Work in partnership with site leadership to realize the site strategy and agreement on QC strategy.
As part of the Global QC leadership team, you will develop, implementing, and monitoring both tactical and operational plans to ensure strategic goals over 1 – 3 years are achieved. You will be responsible for provision of services including: sampling procedures, sample handling logistics, sample storage, testing, and release of results related to GxP regulated processes (e.g. product release testing, in-process testing, raw material testing, stability studies, environmental and utility monitoring testing etc.) in line with local and international regulations.
The Director of QC leads employees in the QC group placing focus on compliance, safety, training, efficiency, reliability, costing, measuring performance, staff development and improvement.
The Director of QC is accountable to ensure that all tests and associated services provided by the Chemistry, Biochemistry, Microbiology and sampling laboratories are delivered on-time and satisfy the relevant Regulatory and Quality requirements.
This is a matrix role, and it is critical to partner with other site roles, other QC heads and respective global functions to ensure the overall company strategic objectives are being met.
This position reports directly to the Global Head Operational Quality Control with a dotted line to the Site Head of Quality.
Functions reporting to this position:
- Sr. Manager, Biochemical QC
- Manager, Chemical QC
- Sr. Manager, Microbiological QC
- Sr. Manager, Sample Management QC
- Manager, Operations Support QC
Site team size typically between 100-200 in total accountability depending on the site and product portfolio complexity.
Ensure a safe working environment in all laboratory areas, maintaining compliance with incident and hazard management systems.
Ensure all release analytics for raw materials, packaging, and finished products are GMP-compliant and completed on time. Lead the local QC management team to resolve escalated issues and ensure systems compliance.
As the primary contact for analytical topics during audits by regulatory authorities and partners.
Oversee investigation and management of out-of-specification results, promoting “right first time” through data analysis.
Bachelor's degree in natural sciences, pharmacy, chemical engineering or related field.
Relevant post graduate qualifications (Masters, PhD) preferred
Business management qualification an advantage
Minimum of 8-10 years' experience in the pharmaceutical, biotechnology or related industry with exposure to GMP or related environment.
Experience in laboratory management involving optimization of operations, testing and platform/method development suitable for use in a manufacturing environment.
At least five years managing large teams (greater than 50 people) and experience managing leaders of leaders and indirect teams.
Experience within global matrix organization an advantage
The expected base salary range for this position at hiring is $185,000 - $205,000. 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.
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.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
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. Learn more Inclusion and Belonging | CSL.