ociate Director QA Manager - GMP 80 - 100
ociate Director QA Manager - GMP 80 - 100
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Noema Pharma is a clinicalstage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.
At Noema Pharma every patient matters.
Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.
We partner with patients their families and caregivers and healthcare professionals to provide a comprehensive approach that goes beyond treating symptoms to ensure that patients experiences perspectives needs and priorities are meaningfully incorporated into our work.
For our fastgrowing team we are looking for an Associate Director Quality Assurance (QA) Manager Good Manufacturing Practice (GMP). The QA Manager GMP is responsible for the GMP quality of all the Noema Pharma products. Furthermore the QA Manager GMP is responsible for overseeing the GMP quality network of our contract development and manufacturing organizations (CDMOs) and Contract Laboratory Organizations (CLOs) service providers.
Tasks
Quality Assurance
- Assure the GMP quality of the Noema Pharma products.
- Oversee Noema Pharmas CDMO and CLO service providers from a GMP quality perspective including the management conduct and supporting of corresponding qualification and requalification audits and evaluations.
- Responsible for the quality technical agreements (QTAs) with Noema Pharmas CDMO and CLO service providers.
- Ensure the batch disposition of Noema Pharmas finished products.
- Closely work together internally with the Chemistry Manufacturing and Controls (CMC) and Regulatory Teams and externally with CDMO and CLO representatives to support product development and operations.
Quality Management
- Implement and foster the Noema Pharma GMP quality system to ensure Noema Pharma meets global regulatory compliance and industry standards.
- Initiate and manage the development review and approval of GMPrelevant procedural documents (proc docs; e.g. standard operating procedures SOPs) in compliance with applicable regulatory requirements.
- Ensure appropriate GMP training of Noema Pharma Personnel.
- Oversee the management of deviations and the resolution of problems including corrections and corrective actions for Noema Pharmas GMPrelevant activities.
- Support continuous improvement of GMP qualityrelated processes.
- Closely work together internally with the CMC Clinical Operations Project Management Regulatory and Safety Teams and within the Quality Department and externally with Noema Pharmas service provider representatives on the development and operations of Noema Pharmas products.
- Support the Quality Department on Qualityrelated tasks and activities.
Compliance
- Ensure readiness of all GMP activities for preapproval and routine health authority inspections.
- Host health authority inspections within the GMP area.
Requirements
- Degree in a scientific or operational discipline relevant to the life sciences arena or equivalent.
- Minimum of 5 years hands on experience in GMP QA for small molecules.
- Minimum of 3 years leadership experience in a GxP area.
- Experience with United States Food and Drug Administration (US FDA) European Medicines Agency (EMA) and International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) GMP requirements.
- Strong analytical and problemsolving skills.
- Experience with conducting GMP audits is a plus.
- Hands on experience with computerized systems validation (CSV) is a plus.
- Excellent interpersonal skills ability to interface and communicate effectively with Noema Pharma colleagues Noema Pharmas consultants and representatives of Noema Pharmas service providers. Ability to influence behaviors and negotiate and resolve challenges with poise tact and diplomacy.
- Very good communication skills in English written and verbal (additional language skill advantageous).
- Excellent planning and strong organizational skills able to manage multiple tasks simultaneously and set priorities.
- Selfmotivated and able to work independently in a fastpaced small company environment.
- Proactive and problemsolving attitude.
- Personal resilience perseverance energy and drive.
- Team player open personality and collaborative attitude.
- Able to travel from time to time to support audits inspections etc.
If your profile matches the above description we are looking forward to your application.
Employment Type
Full Time
