Head Analytical Compliance, Analytical Operations - Ludwigshafen am Rhein, Deutschland - ABBVIE

ABBVIE

Geprüftes Unternehmen

Ludwigshafen am Rhein, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Head Analytical Compliance, Analytical Operations, Biologics Analytical Fulltime or part-time (minimum 80%)**
Primary function

Leads and develops a team covering Compliance, Doc Management, ER/CAPA and Change Management
Develops and implements short and midterm strategy for the Compliance group and manages effectively local and global interfaces (QA, DPD, Regulatory, Operations, etc.).
Develops/aligns local processes/workflows within NBE and NCE ARD Ludwigshafen.
Collaborates with the other ARD sites in the development of global lean processes/workflows and GMP approaches.
Serves as Deputy Head of Quality Control in Germany (tbd).
Is responsible for GMP systems and processes, compliance, and training within area of responsibility.

Management & Development of People / Resources

Innovation & Scientific Leadership

Translates regulatory expectations (guidelines, GMPs and other GxPs as appropriate) in executable approaches aligned with partner functions.
Drives/coordinates local and global initiatives to align and improve processes and workflows.
Adapts to changing environments and balances priorities within function.
Ensures utilization of appropriately risk based approaches to ensure project and internal/external budget success and increase efficiency.

Leadership competencies

Builds strong relationships with peers to create and implement aligned local and global processes as it relates to area of responsibility.

Creates a learning environment, open to suggestions and experimentation for improvement to recruit, develop and retain top talents.
Deals comfortable with uncertainty, ambiguity, and risk to make decisions having midterm impact. Ensures alignment with corporate/regulatory policies/standards.
Steps up and takes leadership to implement changes in the face of organizational or personal challenges.
Raises the bar and drives the function to efficient/reliable execution.
Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.

Education & Experience Required

Degree in pharmaceutical sciences, chemistry, food sciences or related field
Minimum 5 years of experience in the pharmaceutical industry with exposure to analytical and/or formulation development and sound expertise in GMP areas.
Knowledge of global GMP requirements and regulations and experience with their implementation in welldefined and efficient processes and workflows.
Prior management experience leading smaller teams.