We at Kiadis Pharma, a Sanofi Company are focusing our research
& development on NK cell therapeutics, leveraging the natural
strengths of our immune systems to source the best cells for
Are you a quality assurance expert that has a track record of
GMP projects and is ready to deliver crucial input? Are you a
strong communicator, charismatic influencer and able to effectively
manage leadership encounters with a high sense of integrity? Are
you interested in working remotely and based in the Boston area (or
willing to relocate)? Read-on.
As a QA Manager you will be responsible for the coordination of
quality operations of both in-house and outsourced manufacturing
and ensure that the production and quality control activities are
performed in compliance with GMP/GDP requirements. The scope of the
role includes oversight of in-house manufacturing, CMO
manufacturing and QC release testing laboratories operations. In
your day-to-day you will:
Ensure the production and control activities performed at Kiadis
manufacturing and testing locations are in compliance with GMP
requirements and quality agreements.
Participate in regulatory inspections at Kiadis manufacturing
and testing locations as required.
Perform audits of the Kiadis suppliers and service providers as
Lead effort in continuous improvement of GMP compliance.
Provide guidance and support to Kiadis manufacturing and testing
staff concerning compliance with relevant quality and regulatory
policies and the development of strategies to improve quality
working practices and systems.
- Build cross functional relationships to support Quality
Operations throughout Kiadis organization and at CMO or testing
The ideal candidate
We are looking for someone that shares our love for cells, and
likes being part of a dynamic organization. It would be great if
you have the following requirements:
University degree in biomedical and/or life sciences.
Minimum of 8 years of QA Pharmaceutical/biotechnology
In depth experience with Quality Systems and Quality Management
In depth knowledge of EU & FDA regulatory agencies
Experience overseeing contract manufacturing and testing
Knowledge and experience in international GMP and regulation
- Excellent communication skills, both oral and written.
What we offer
People from all over the world, together as one team, contribute
to improving the lives of patients every day. We offer an exciting
position in an innovative, dynamic and inspiring environment where
you'll receive a competitive remuneration package, autonomy and the
opportunity to make your own mark within Kiadis.
We create an environment where ideas are shared, experiences are
impactful, and talent is developed. Because of our inclusive and
family-like environment, you will always have the feeling of
belonging & appreciation.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for