- Languages English
- Experience Senior (+5 years)
Are you looking for a challenging new opportunity in a fast growing biotech company? Are you an autonomous individual, with strong experience in supplier quality and regulatory affairs?
Our client, a pioneer in biotechnologies based in Switzerland, is looking for a Senior Associate, Global Supplier Quality.
The main purpose of this position is to manage the QA interface with manufacturing and testing partners by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.
The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, as well as the organization and conduct of quality management reviews with CMOs.
The role also includes quality management of the product lifecycle management in relation with contract manufacturing, and support to CMC functions such as review and approval of regulatory filings.
- Be responsible for quality aspects related to contract manufacturing organizations (CMOs) including Local QMS improvement, alignment of quality processes and systems
- Ensure quality issues are investigated and CAPAs are defined, implemented and evaluated as well as Change Controls
- Provide technical support for the manufacture of product at CMOs and ensure that they maintain quality systems that are in the state of compliance.
- Provide support and oversight on the Quality Systems improvements and roll out
- Participate and support regulatory inspections at CMO, CMC and audits
- Perform trend analyses and take actions as adequate. Perform the periodical evaluation of the performance of CMOs in collaboration with other concerned departments.
- Organise and participate to Quality review meetings at all CMOs and partners
- Manage all QA activities related to the implementation and maintenance of serialization processes at CMOs in compliance with the various national or regional regulations.
You have a strong background in life sciences, in depth knowledge of supplier quality, strong experience in regulatory affairs, GxPs, for pharmaceutical or biotech industries (>4 years) .
You also have the following competencies and skills:
- Minimum Bachelor’s degree, Master degree preferred in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry, etc.)
- Sound experience in quality management with external partners, regulatory or quality
- Understanding of GxPs, quality systems and regulations (FDA and EU, other geographies’ regulations is a plus
You are also a team oriented individual with good communication skills. Finally, you are fluent in English, other languages a plus.
Are you ready to join an innovative and fast paced company, while undertaking a key role in its future growth?