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

CSL Plasma•Kankakee, IL

1d•$166,000 - $196,000

About The Position

Responsibilities: 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. Principal Accountabilities: 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. Qualifications: 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. Sterile Biopharma experience highly preferred. 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 Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. The expected base salary range for this position at hiring is $166,000 - $196,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. About CSL Behring 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. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . You Belong at 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. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

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.