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CSL · 2 days ago

Assoc. Director, Quality Value Stream Lead- Bulk/Fractionation

Kankakee, IL

Full-time

Onsite

Director/Executive

$166K/yr - $196K/yr

8+ years exp

CSL is a global biotherapeutics leader driven by our promise to save lives. The Associate Director, Quality Value Stream Lead is responsible for quality oversight of manufacturing activities, ensuring compliance with global standards, and fostering a culture of continuous improvement within the team.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Oversees all Quality related activities that support within the Value Stream to support the process. Ensures team of Managers are aligned to priorities and to the responsibilities defined in the QA Accountability Matrix SOP. Associate Directors drive the Quality Operations team within the Value Stream

Responsible for product quality and compliance within the site value stream. Partners with all teams within the site value stream regarding product quality aspects

Accountable to manage all batch documentation review per unit operations and issue final batch disposition recommendation

Oversight of deviation business processes as tailored to Value Stream Operations to meet the DIFOT schedule to ensure consistent supply of product to patients. Assures compliance to global SOP for Deviation Management

Leads the respective teams to facilitate new ways of working to develop the desired culture within relevant quality areas

Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of 'non-value added' activities

Responsible for the management and execution of performance management process. Development of department personnel for Quality Assurance Operations including talent management process

Places a high priority on developing others through coaching, feedback and developmental goals

Qualification

QualityComplianceGMP experienceLeadership experienceSterile Biopharma experienceBatch dispositionGlobal Health Authority regulationsScientific degreeCoachingCommunication skillsMentoring

Required

Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred

8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years' leadership/team management experience

Significant experience in: Quality and Compliance in pharmaceutical manufacturing

Understanding or the ability to understand technical aspects of manufacturing, in order to diagnose issues and improve performance

Experience in Batch disposition

Strong understanding of Global Health Authority expectations, regulations and inspections. Proven ability to apply this understanding to support patient health

Leadership and influencing skills – In person and through written communication or presentation