Director Analytical Services Quality (f/m)
Our customer is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies to treat rare, often life-threatening conditions. On behalf of them we are looking to fill the position of Director Analytical Services Quality (f/m).
Main responsibilities and accountabilities:
- Leads, motivates and develops department and direct reports in line with the company values and the Marburg leadership promise
- Ensures education and training of department staff to maintain and further develop know-how and meet applicable cGMP standards.
- Develops and defines strategic direction of Analytical Services Quality (ASQ).
- Responsible for the effective management and operation of Analytical Services Quality (ASQ) Marburg. Defines objectives for the department in alignment with the objectives of the company and assures availability of adequate performance indicators for the department.
- Ensures timely, efficient and GMP-compliant performance and documentation of all quality tests for starting materials, IPCs (in process controls), active pharmaceutical ingredients, packaging materials including medical devices, final products and manufacturing environment according to applicable quality rules to warrant product quality and safety. Assures efficient processes, data integrity and timely availability of data to all customers.
- Assures that the Quality Control documentation and its archiving comply with cGMP and regulatory requirements and support regulatory filings (change control).
- Responsible for the continuous improvement of general processes in the department. Contributes to continuous improvement of processes and products in the company.
- Assures maintenance of legal and internal health and safety standards.
- Responsible for the assigned CSL Behring products as `Leiter der Qualitätskontrolle` according to AMWHV and to internally assigned tasks (SOP 505401).
- Strong accountability for developing relationship with key stakeholders in projects as well as daily routine.
Qualifications and experiences:
- PhD in Natural Sciences or Pharmacy or equivalent
- At least eight years of experience in pharmaceutical or diagnostic industry and with GxP requirements
- Experience in building effective teams and leadership of teams of a significant size
- Experience in Quality assessment of biological pharmaceutical products and international inspections
- Knowledge in protein analytics, especially blood proteins
- Knowledge of international requirements regarding cGMP and analytical testing of medicines
- English and German fluently in speaking and writing
- Drives results, directs work and ensures accountability
- Communicates effectively
- Develops talents, drives engagement and builds effective teams
- Optimizes work processes and cultivates Innovation
- Manages ambiguity, situational adaptability
We look forward to receiving your application! Should you have any questions in advance please call:
Dr. Andrea Sandmöller
email@example.com, Tel. +49 172 35 46 586
NotchDelta Executive Search - Rheingaustrasse 190 - 65203 Wiesbaden, Germany