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Quality Systems Manager

Employer
CSL
Location
Boca Raton, FL
Start date
May 1, 2024

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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

1. Provide guidance to department personnel in resolving discrepant/missing information required for these reports and ensure follow-up with regulating agencies.

2. 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.

3. 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.

4. 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.

5. 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.

6. Assess and design departmental Standard Operating Procedures (SOPs) for all processes to ensure compliance with regulatory and customer requirements.

7. Mentor others on data analysis, technical problem prevention and resolution, design control procedures, investigation processes, and methods as it relates to quality systems.

8. 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.

9. Manage an annual budget designed to exceed objectives by review of performance against goals.

10. Perform other duties, as assigned, to support our needs.

Your Qualifications
  • 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

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 https://cslbenefits.com/cslp.

About CSLPlasma

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!

Company

CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

Areas of Expertise

We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.

Rare & Serious Diseases

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.

Vaccines

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. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.

Iron Deficiency & Nephrology

With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women’s health, we help patients affected by these conditions to live better, healthier lives.

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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