- Provide guidance to department personnel in resolving discrepant/missing information required for these reports and ensure follow-up with regulating agencies.
- Manage compliance to and successful use of the Quality System tools such as change and deviation management. Ensure regular management review of quality performance that delivers stable, high levels of compliance performance in assigned QA areas. Provide leadership and coordination to established automated systems for control. Provide QA oversight/approvals to New Center change control process.
- Manage Key Performance Indicators (KPIs) performance to ensure meeting regulatory and departmental requirements, and to improve department processes. Work with CSL applicable systems to analyze and identify quality issues/trends and report those to appropriate Sr. Management.
- Provide regulatory and SOP requirements for completion of lookbacks, and BPDRs guidance to plasma centers. Manage quality applications workflows, including DTAC, Plateau, Change Control and Deviation Management. Manage new systems, workflow changes, quality projects, and change control efforts.
- Manage improvement opportunities for quality systems to ensure there are tools in place to support processes for deviation management, root cause analysis, preventive action, and effectiveness monitoring. Manage the change control systems to ensure compliance and communication measures are completed before deployment of change.
- Assess and design departmental Standard Operating Procedures (SOPs) for all processes to ensure compliance with regulatory and customer requirements.
- Mentor others on data analysis, technical problem prevention and resolution, design control procedures, investigation processes, and methods as it relates to quality systems.
- Collaborate with the Global IT Quality Team and Quality Management Delegate(s) to ensure coordination of activities between the IT QMS and site quality system.
- Manage an annual budget designed to exceed objectives by review of performance against goals.
- Perform other duties, as assigned, to support our needs.
- University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, or Biochemistry)
- 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry- Knowledge of current Good Manufacturing Practices (cGMP) principles
- Knowledge of FDA and EMA requirements
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Quality Systems Manager - Boca Raton, United States - CSL Plasma
Description
The Opportunity
Reporting to the Associate Director of Quality Systems - Manage staff, including selecting, training, developing, coaching and terminating, as applicable with guidance from Human Resources. Ensure accurate reporting of all consignee notifications (Lookback/Lookforward), Biologic Product Deviation Reports (BPDRs), and recalls consistent with customer and regulatory requirements.
This position is located on site in Boca Raton, FL.
The Role
Your Qualifications
Our Benefits
CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit .
About CSL Plasma
CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma ) .
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 Plasma
R
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.
