Head of Compliance (m/f/d)

작업 내용

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 the second largest influenza vaccine company 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!

For our Value Stream Base Fractionating in Marburg we are looking for a

Head of Compliance (f/m/d) - R-144911

(fulltime/ permanent)

Position Purpose

The main responsibility of the role is to drive and maintain Quality Assurance systems to ensure cGMP compliance and a best in class Right First Time (RFT) approach (deviation management, change control, SOPs, training, data trending and analysis) within the respective Value Stream.

The job incumbent is a key player to represent the Value Stream both during critical deviation investigations as well as in internal, customer and regulatory audits. The role might act as Compliance representative/SME on behalf of the Value Stream in projects or other initiatives.

The compliance to relevant Global Quality Policies should be ensured while the respective SOPs and/or working instructions are continuously monitored to be well compliant, if necessary to be revised accordingly.

Main Responsibilities and Accountabilities:
Provides leadership while motivating, developing and leading the team according to CSL values and principles.
Approval of production protocols according to §14 AMG (German Medicines Act)
Leads/coordinates complex deviations, identification of the right root cause (RC), identification of smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
Performance of data analysis and trending as a tool to foresee/tackle potential compliance/process issues (e.g. IPC warning limits excursions, drop in yields) in a proactive manner, as a tool to identify potential opportunities for process improvements and/or to understand root causes of more complex compliance/process issues right to initiate an appropriate remediation.
Supports preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required and ensure optimal inspection readiness
The job incumbent is a key player to represent the Value Stream both during critical deviation investigations as well as in internal, customer and regulatory audits.
Establishes and maintains GMP training, site quality policies, SOPs and practices to ensure a compliant production (cGMP, safety, environmental protection, health care, lean)
Initiate, coordinate and/or assessment of change controls. Ensure a compliant RTO (release to operation).
Ensure adequate training status across the respective Value Stream (cGMP compliance, safety and environmental protection)
Might act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives.

Position Qualifications and Experience Requirements

Master degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
5+ years of professional experience in the pharmaceutical/biotech industry with specific knowledge in Quality and cGMP compliance including 3+ years’ leadership/team management experience
Proofed experience in occupational safety and continuous improvements methods
Experienced in inspection situations with authorities (e.g. US FDA , Local German Health Authorities/Regierungspräsidium)
A Lean Six sigma Green Belt training is favorable

Marburg, 20.08.2021

CSL Behring GmbH

Human Resources

Worker Type:
Employee

Worker Sub Type:
Regular