For our Value Stream Base Fractionation department, we are looking for a

Head of Operational Services (m/f/x) -

R-247780

Fulltime / permanent / Non-tariff

The main responsibility of the role is to drive and ensure the compliance (deviation management, Right first Time (RFT), GMP compliance, SOPs, training, change control, BRR, detailed scheduling, documentation, data trending and analysis, and handling of SAP data) of the VS.

Provides Quality Compliance oversight for the VS on the Marburg Manufacturing site.

The occupant acts as the Subject Matter Expert and will ensure the department is adequately represented during critical investigations, projects, internal, customer and regulatory audits.

Develops and implements functional policies and procedures to continually improve product quality, and compliance in manufacturing processes.

• Responsible for review and approval of production protocols in the Value Stream according to §14 AMG (German Medicines Act)
• Support Value Stream Lead in developing people to meet both their career goals and the organizational targets. Support in creating a climate where people are motivated to do their best
• Develop and implement policies and practices to ensure a compliant production (c-GMP, safety, environmental protection, health care, lean) and ensure implementation
• Ensure the value stream provides efficient, effective and compliant execution of quality responsibilities to assure that only materials and products that are safe and fit for purpose are released into the facility, transferred to other values streams, other sites or into the market.
• Ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third-party audits and the initiation of analysis of inspection results as well as corrective and preventative actions and contributing that the responses to authorities are given in a timely manner
• Ensure the required training and perfom GxP trainings for the staff of the VS (c-GMP, safety and environmental protection)
• Identify measures to optimize the economic benefit and efficiency of the VS (e.g. production throughput, yields, lot sizes and labour costs).
• Interface to global functions and other CSL Behring VSs by sharing experiences and know how.
• Compilation of risk assessments
• Act as the Subject Matter Expert for the VS and represent the department during critical investigations, projects, internal, customer and regulatory audits

• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 8 - 10 years of experience in the pharmaceutical/biotech industry with specific knowledge in a variety of disciplines, e.g. Quality, Manufacturing, Process Engineering, Regulatory. including 3+ years' leadership/team management experience.
• Proven experience in occupational safety and continuous improvements methods
• Huge experience with inspections by authorities (FDA (CBER, CDER), Regierungspräsidium) Preferably a Lean Six sigma Green Belt training
• Fluency in English

• Excellent income potential and extended benefits
• Two additional leave days for your personal wellbeing
• Childcare "Kita Frosch König" for up to 14 children
• Find Diversity, Equality, and Inclusion at all sites and with every colleague. Come as you are
• Extensive management/leadership programs.