Global Product Quality Manager

Country:  Chile
City:  Santiago
Department:  Global Operations & Production
Job ID:  42185

Job Grade:  

Hiring Manager: Carlotta Pasculli 

Internal Posting Date:  - 

 

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

 

What the job looks like:

 

•    Ensure regulatory CMC compliance of all supervised medicinal products with national and international guidelines/regulations and with the relevant Marketing Authorizations in order to gain and/or maintain registrations
•    Providing critical assessment and strategic input, flagging risks, proposing mitigations as well as highlighting opportunities for Grünenthal for the quality part of dossiers to maximize chances of success for approval.
•    Issue and provide regulatory CMC documentation, Active Substance Master Files (ASMFs) and CMC documentation (Module 3 and 2.3), timely and in due form by considering current and relevant guidelines to support obtainment and maintenance of national and international regulatory registrations. Preparation of responses to pharmaceutical questions from Authorities (e.g. deficiency letters, requests) 
•    Support in maintaining respectively obtaining Certificates of Suitability (CEPs) and Marketing Authorizations (MAs) for APIs respectively medicinal products
•    Responsible for interacting with stakeholders from e.g. Regulatory Affairs, Supply Chain, Production, Quality control and other key functions, and representing GQA CMC in cross functional teams
•    Ensure product-related regulatory CMC support for Affiliates, License Partners and Third Parties
•    Collaborate with the manufacturing site in order to give QA support to maintain regulatory compliance of the manufacturing processes and to ensure regulatory compliance of all changes to the processes.
•    Responsibility for the coordination, regulatory evaluation and implementation of product-related changes. 
•    QA-CMC support in preparation of Technical Agreements with contract manufacturers, other manufacturing site, Affiliates, and Suppliers (e.g API) in order to assure regulatory compliance.
•    Involved in review of available manufacturing instructions, stability protocols, test instructions and validation protocols for products manufactured in-house and by contract manufacturers (as laid down in respective agreements) with regard to regulatory compliance.
•    Support in preparation of Product Quality Reviews 
•    QA-CMC regulatory support of product transfers. Review of relevant documentation, e.g. transfer documents and testing documentation to ensure regulatory compliance.
•    QA-CMC support of the manufacturing site and CMOs concerning Change Control System in order to assure regulatory CMC compliance 
•    Supporting due diligence and partnering activities as assigned
•    Take-over of project-orientated special tasks in accordance with instructions by Head CMC Compliance Internal Manufacturing LatAm.

 

What you'll bring to the table:

 

Professional experience:

At least 3 years experience in lifecycle Regulatory CMC preferably for NCEs, Biologicals and knowledge on Medical devices (Drug product combinations)
Sound experience in GMP environment 
Educational background:

Grade as pharmacist or other natural science (e.g. chemist, biologist)
Ph.D. in Natural Science (not mandatory)
Personal skills & competences:

Self-dependent and independent way of working
Excellent team working 
Global and service-oriented mind-set, strong sense of cultural/diverse backgrounds 
Excellent interpersonal, oral and written communication skills and abilities, positive attitude 
Decision making capabilities, also in difficult situations 
Accommodative and flexible way of working 
Best Understanding of Continuous Improvement and Process Excellence
Good English knowledge in writing and communication plus other language preferably Spanish or German


 

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About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

Your HR contact: 
Carla Godoy Valle

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal