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

CSL

2d • $166,000 - $196,000

About The Position

The Associate Director level in QA, directs the team, sets expectations, mentors / coaches the staff and holds Managers accountable. ADs will have knowledge of Global policies, regulatory requirements, and are accountable for Compliance within their department. They will perform level-appropriate reviews (finished documents) and final approvals. This role is responsible for quality oversight of the activities within a manufacturing Value Stream – Fractionation. This includes operational quality management in the area to assure appropriate quality of the products manufactured within the value stream, adherence to any applicable CSL standards and procedures, review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and monitoring and continuous improvement of quality performance metrics.

Requirements

• 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

Nice To Haves

• Sterile Biopharma experience highly preferred.

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.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees