You lead a team focused on qualification and sample management, ensuring regulatory compliance while driving process improvements and developing team members' skills for optimal performance.
Anforderungen
- •Master’s degree in relevant field
- •4 years relevant industry experience
- •2 years work experience in GMP
- •Good knowledge in analytical equipment
- •Solution-oriented mind-set
- •Strong communication skills
- •Ability to lead and inspire a team
- •Proficiency in English
- •German is beneficial
Deine Aufgaben
- •Lead and develop a team of qualification experts
- •Manage resources to support late-phase Bx portfolio
- •Establish strategies for analytical instrument qualification
- •Drive continuous improvement in sample management processes
- •Ensure compliance with regulatory requirements and GMP
- •Represent department in internal and external audits
- •Perform GMP risk assessments and provide technical guidance
- •Train and develop team members for professional growth
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Original Beschreibung
# Senior Manager / Qualification & Sample Management
**Schaftenau** | **Full time**
**Job Description Summary**
As the operational manager of the Qualification & Sample Management Team, you foster collaboration and leadership by guiding the team in technical aspects, while managing associated capabilities and capacities. You drive strategic initiatives for qualification of state-of-the art analytical instruments and related software in a GMP setting and ensure regulatory compliance. Additionally, you support team members in their professional growth through mentoring, coaching, and providing opportunities for development.
**Job Description**
**Your key responsibilities**
* Lead and develop a team of highly motivated qualification and sample management experts
* Manage associated resources, capabilities and capacities to ensure optimal support of our late-phase Bx portfolio
* Establish and drive strategies for qualification of state-of-the art analytical instruments and related software under Good Manufacturing Practice (GMP) in alignment with our local and global stakeholders
* Continuous Improvement of sample management and shipment processes in a global organization including import and export of pharmaceutical material
* Ensure compliance with regulatory requirements, including GMP guidelines and industry best practices. Representing department in internal and external audits
* Perform GMP risk assessments & provide technical guidance for trouble shooting activities related to analytical equipment
* Train and develop team members to enhance their technical skills and ensure their professional growth. Recruit and develop team members as well as establish a culture of high performance and trust
**What you’ll bring to the role**
* Master’s degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry in a GMP regulated environment
* Good knowledge in analytical equipment qualification within GMP environment
* Solution-oriented mind-set with the ability to adopt to change and strong communication skills
* Ability to lead and inspire a team
* Proficiency in English (and German is beneficial)
**Desirable requirements**
* Ability to work and lead (a cross-functional team) in a matrix setup
* Knowledge in SAP and LIMS application
**Skills Desired**
Coaching, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model