You ensure compliance with quality standards while fostering collaboration and communication across teams. Your role involves promoting a positive work environment and supporting employee development to drive operational success.
Anforderungen
- •PhD or Master's Degree in chemistry
- •Bachelor's Degree with significant experience
- •Minimum of 10 years' experience
- •Minimum of 5 years leading a team
- •Extensive experience in GMP compliance
- •Expertise with health authority inspections
- •Proven leadership skills
- •Track record of developing high-performing teams
- •Strong strategic thinking abilities
- •Problem-solving and decision-making abilities
- •Experience in continuous improvement culture
- •Experience in lean leadership
Deine Aufgaben
- •Ensure compliance with quality and regulatory standards.
- •Establish and monitor an effective compliance system.
- •Promote collaboration with GMP organizations in PTD Basel.
- •Facilitate knowledge sharing across PTD regions.
- •Act as a change agent for GMP processes.
- •Collaborate with development and operations teams.
- •Drive alignment across the PTQ network.
- •Create a strong team spirit and effective communication.
- •Foster employee development and ensure resource availability.
- •Establish a safe working environment for growth.
Original Beschreibung
# Section Lead GMP Support & Compliance
**Basel** | **Full time**
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### The Position
We advance science so that we all have more time with the people we love.
At the Basel Site, the Synthetic Molecules Technical Development (PTDC) area is responsible for the technical development of our Synthetic Molecule pipeline of Drug Substances (DS) and Drug Products (DP) for clinical trials.
Operations Support & Compliance (PTDC-T) is responsible for providing support to all GMP and non-GMP operational activities within PTD organizations located at the Basel site. By providing high-quality support to our partners, PTDC-T enables the development of pharmaceuticals and the manufacturing of clinical supplies.
Within PTDC-T, the GMP Support & Compliance section acts as a centralized GMP-enabling team for all processes and organizations in the scope of cGMP regulations in PTD Basel. The team ensures seamless collaboration across PTD GMP organizations and many internal and external partners who contribute to the development and manufacturing of clinical supply materials.
### The Opportunity
As a Section Lead, you will
* Ensure adherence to quality standards with all applicable regulations, including current GMP and regulatory standards. Establish an effective compliance system, own and monitor the compliance status, inform about significant problems and opportunities regarding quality and regulatory compliance, and ensure appropriate actions are taken to maintain and improve compliance.
* Ensure seamless collaboration with GMP organizations in PTD Basel. Promote the harmonization of practices and processes and facilitate knowledge sharing across PTD regions (SSF, PZ, BSL, KAU).
* Be an active and visible change agent, promoting flexible and open mindsets to a centralized team that owns and maintains the GMP processes for PTD Basel.
* Be a strong partner for development and operations at the network and collaborate closely across the PTQ network and with other PTD functions to drive One Quality Voice and ensure operational alignment.
* Create an environment of strong team spirit, timely and effective communications, a sense of urgency, high motivation, and inspire teams to achieve goals in the immediate and longer term.
* Ensure that the development of employees is fostered, business critical resources are available, and a safe working environment is established where employees grow and thrive. Embody PT lean leadership principles and methods while fostering a continuous improvement mindset.
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### **Who you are**
* PhD or Master's Degree in organic chemistry, analytical chemistry, pharmacy, or associated sciences. Alternatively, a Bachelor's Degree with significant experience in the pharmaceutical industry.
* A minimum of 10 years' experience in the pharmaceutical industry, with a minimum of 5 years leading a team.
* Extensive experience in GMP compliance, including broad expertise with health authority inspections. Experience within a technical development environment is a plus.
* Proven leadership skills with a track record of engaging and developing high-performing teams.
* Strong strategic thinking, problem-solving, and decision-making abilities.
* Experience in fostering a culture of continuous improvement and lean leadership.
If you are an experienced People Leader who enjoys change management to build high performing teams, we would love to hear from you.
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**Roche is an Equal Opportunity Employer.**