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The Opportunity

The Assistant Manager Quality (AMQ) reports to the Associate Director Quality.

The Role

Responsible for establishing and implementing effective Quality systems.

• Ensures the activities and controls used to determine the accuracy and reliability of the establishments’ personnel,

equipment, reagents and operations in the manufacturing of blood products including testing and product release

• Collaborate with center management to ensure compliance with all relevant regulations, laws, standards and

Company policies, and that the Center is always “inspection ready”

• Lead quality team to ensure all staff is competently performing their duties as evidenced by findings of a program

of monitoring, tracking and trending of key metrics

• Responsible for hiring, retention and development of quality staff

• Lead investigations to determine root causes, corrective/preventative actions and appropriate

coordination/leadership of process improvements

• Proactively facilitate communication and interdepartmental coordination quality issues and host audits

• Responsible for the oversight of the training activities, policies and processes at the Center level

Responsabilities

Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs),

compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, nonconformity

discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality

management as to the state of quality and systems at the center.

Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance

to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis

of KPIs, root cause and failure mode impact assessment and change management.

Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example;

consistently motivate staff through education to high levels of competency that drive success in a dynamic and

regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance

reviews and enact corrective actions, up to and including termination.

Participate with management to develop programs and methods to streamline center processes resulting in

improved customer/donor service, product yields and financial results while maintaining compliance and quality.

Working knowledge of the change management process and appropriately raise ideas for consideration for change

locally and upward to quality and area management.

Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report

concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for

remedial actions to resolve audit observations and other non-compliance issues of deficiencies.

Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center

review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilize

quality tools and applications to facilitate understanding of issues and documentation.

Maintain clean efficient work environment and ensures enough operating supplies and availability of forms, as

needed. Comply with all Environmental Health and Safety (EHS) and Occupational Safety and Health Administration

(OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary.

Promote safety in all actions.

Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate

effectively with HR to ensure HR compliance and ensure center management is doing the same.

Comply with all federal, state and local regulatory and company policies and procedures.

Responsible for notification to the ADQ for any event that negatively affects the safety, quality, identity, purity or

potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated

to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality

Systems and Assurance.

Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures

associated with hyperimmune programs at the center if applicable.

Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness

checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved.

Participate in Center leadership team meetings to understand center training needs and collaborate with center

management when viewing the Quality Management System to identify, coordinate and deliver retraining for the

purpose of correcting or improving operational or quality issues.

Perform other quality duties as assigned.

Education

• Bachelor’s Degree preferred

• Equivalent combination of education and professional work experience required

Experience

• Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of

others, OR

• 1-year Quality experience required OR Completion of CSL Plasma Leadership Development

program

Additional Comments

• Maintain company Technical Training certification

• Knowledge of ever-changing and complex government and industry regulations, and ability to

monitor compliance with these regulations

• Proficient in English

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 (https://www.csl.com/careers/how-we-care-for-you-at-csl) at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL (https://www.csl.com/our-company) .

We want CSL to reflect the world around us

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 (https://www.csl.com/careers/inclusion-and-belonging)

Do work that matters at CSL!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement