Quality Assurance & Regulatory CMC Manager

Do you want to be part of Ascelia Pharma – an ambitious, young, orphan-oncology life science company? Are you motivated by building a company that delivers products with high quality that will improve the lives of patients with rare oncology related diseases?
Ascelia Pharma is a life science company focused on orphan oncology. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. We have two drugs in clinical development and aim to further expand our drug pipeline in therapeutic areas that leverage our unique expertise in taking orphan oncology drugs through clinical stage development and commercialization.
We are looking for a Quality Assurance and Regulatory CMC Manager who will take a leading role in developing the quality system and ensuring that the company is ready for our journey in delivering new pharmaceutical products.
This role is a shared roll between Quality Assurance and Regulatory with focus on Quality Assurance, but you will also be responsible for providing CMC regulatory guidance and support for the Ascelia Pharma product portfolio. You will report to the Regulatory Affairs and Quality Assurance Director.
Your main tasks
Establish, maintain, and continuously improve the Quality Management System, QMS, and assure it fulfill the global Health Authority and ICH quality requirements.
Initiate and drive Quality Assurance changes to improve process within the company.
Summarize and report Quality Management System gap assessments, Quality Management Review and Product Quality Review.
Prepare and perform internal audit and audit at CMO/CRO audits as well as support in regulatory authority inspections.
Initiate and perform non-conformities and CAPA investigation, assure CAPA actions and evaluate change control when necessary.
Perform training within GXP and coordinate training plan for the staff at Ascelia Pharma.
Plan and prepare filing of regulatory CMC section of assigned IND, CTA, MAA and NDA submissions.
Review of CMC documentations to be included in regulatory dossiers.
Provide regulatory CMC support and guidance to cross-functional teams and ensure all applicable global regulatory CMC and ICH requirements are considered and appropriately incorporated into clinical and commercial products.
Prepare responses together with the CMC function to inquiries from regulatory authorities related to CMC activities.
Other duties, as assigned.



Your qualifications
To master the position as Quality Assurance and CMC Regulatory Manager you hold a Bachelor’s or Master degree within natural science or similar, and have a track record from working with quality assurance in a similar position and have:
three years or more of work experience from quality work within eg. quality control, quality assurance and/or manufacturing in pharmaceutical industry.
at least five years of experience in the pharmaceutical industry.
solid GXP knowledge, as well as good knowledge of regulations and guidances (eg GMP, 21 CFR Part 820, ICH Quality Guidelines)
solid IT skills
good knowledge in Swedish and high proficient in English in both speech and writing
work permit to work in Sweden.



As a colleague, professional and leader you:
are excited about the Ascelia Pharma’s product portfolio and opportunities ahead.
have the ability to plan and prioritize the department’s goals and own work as well as to implement cross-functional collaboration between departments and have a holistic view.
are open minded and have high integrity, courage, and focus.



Travelling: The position will require some travelling.
Work location: Able to work primarily from the head office at Hyllie in Malmö.
At Ascelia Pharma, your skills, dedication, and engagement help us improve the lives of people living with cancer. We offer you an opportunity to be part of a fast-growing company with global reach, where engagement, dedication and results are met with opportunities for individual and professional development.
Join us on our journey to improve patients’ lives and build a global orphan oncology life science organization.
How to apply
Please submit your resumé and cover letter, along with any other material, as soon as possible but no later than 15 May.
Applications will be reviewed on an ongoing basis. All applications must be in English and are treated confidentially.
For more details about the job or the company, please contact:
Marie Källström
Regulatory and QA Director
Phone +46 (0)735 17 91 20
Or
Carin Linde
Director of Pharmaceutical Development and Manufacturing
Phone +46 (0)735 17 91 14
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.