Director, Global Quality Systems Shared Services

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jul 18, 2021
Ref
R-136583
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary:

The Director of Quality Systems Shared Services is responsible for the operation, life cycle management and continuous improvement of Seqirus Quality Systems for Learning Management, Document Management and Laboratory Information Management designed to meet global GXP compliance requirements, industry standards and business needs.

The role will include developing relationships, and mechanisms for effective communication with internal business customers, and ensuring adequate support to promote an inspection-ready state of compliance in all GXP functions and global sites. This role will participate in, and aid in the communication of, the strategic development of Seqirus’ Quality programs.

Major Responsibilities:
  • Manage a Shared Services team consisting of global Business Process Owners (BPOs) and local Business Process Experts (BPEs) responsible for the Seqirus Quality Management systems for documents/records (EDMS), training & knowledge management (LMS) & Quality Management System (QMS)
  • Lead the team in the definition of these systems, its processes, electronic applications/systems interfaces and organizational structure suitable for implementation and efficient operation across the globe.
  • Lead the strategy for development of appropriate documented policies and procedures for EDMS, LMS and QMS including communications and training plans to support rapid stabilization upon transition/roll-out across the enterprise.
  • Provide strategic business oversight of IT systems used for documents, records, training and laboratory information management; providing strategic input to IT projects and ensuring a mechanism of continuous improvement is established.
  • Partner with IT to raise capital projects to develop (via cloning, green-field projects), and to deploy aligned workflows and relational databases to support compliant quality operations enterprise-wide.
  • Provide coaching and oversight toBusiness Process Owners (BPOs) to ensure they are effectively leading their respective system Applications Steering Committees to deliver this agenda.
  • Utilize understanding of relevant regulations, quality systems and business processes in order to identify mutually agreeable technical options that comply with regulations.
  • Provide oversight to BPOs to ensure robust system life cycle management (LCM) Plans are developed in collaboration with internal stakeholders and incorporate the key recommendations into the annual budget and workplan objectives.  Responsible for ensuring timely implementation of these objectives and thus drive continuous improvement within their systems.

Minimum Requirements:
  • Bachelor’s degree or equivalent education in a related scientific, business, process/industrial engineering major.
  • 10+ years quality experience in pharmaceutical or other related regulated industry; demonstrated management experience
  • 7+ years successful management experience in Quality or Operations in highly regulated environments globally. 
  • 3+ years experience managing cross- site and/or cross- functional projects of significant complexity.  History of substantial business value-adding productivity or several moderate Operational excellence improvements delivered.
  • Expert knowledge of GxP regulations and industry expectations for documentation, records, training, knowledge management and laboratory information management processes and systems.
  • Strong technical understanding of IT applications development process per recognized International Standards (i.e. GAMP5) used in Quality Management processes.
  • Demonstrated ability to lead highly productive teams who are driven to meet customer expectations and optimize processes. 
  • Excellent leadership skills required with a proven ability to lead global teams.
  • Demonstrated ability to think strategically and to work collaboratively using risk-based, proactive approaches to operations problem-solving
  • Excellent analytical, written and oral communication skills for both strategic and tactical messages