Section Lead GMP Support & Compliance
Section Lead GMP Support & Compliance
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Salary Not Disclosed
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
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.
Who you are
PhD or Masters Degree in organic chemistry analytical chemistry pharmacy or associated sciences. Alternatively a Bachelors 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.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Employment Type
Full-Time
