Senior QA Manager Validation & Quality
SallyQ ABThe role
The QA group at Hansa Biopharma is growing and is now seeking a Senior QA Manager Validation and Quality. The QA group consists today of six colleagues who all work at the Lund office. Hansa is a growing, biotech company with a strong R&D pipeline as well as a commercial product within rare disease.
As Senior QA Manager, you will contribute with your deep expertise in validations (e.g of process, cleaning and analytical method) from a quality perspective as well as with your extensive knowledge in quality systems, supplier qualification, and risk-based compliance. You will act as a subject matter authority for validation and QA processes, supporting cross-functional teams and driving quality excellence across internal operations and external suppliers.
Key tasks and responsibilities:
Provide strategic and operational direction for Quality Management, and support validation, process development development and external manufacturing activities.
Oversee development and implementation of quality and validation processes to ensure compliant processes for development, clinical and commercial supply.
QA review and approval of validation documentation.
Quality Supplier Management including guiding external manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives throughout the product Life cycle.
Support authority inspection and internal Hansa/external audits of suppliers and vendors.
Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain
Establish and maintain strong relationships with internal and external stakeholders to ensure execution of QA strategies and operational tasks.
Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement.
Your Profile
We believe you are a Senior QA Professional with a broad background in Quality and Validation across both drug substance (DS) and drug product (DP) manufacturing. You are thorough, results-oriented and communicative, and motivated by progress and the sense of moving things forward. You collaborate easily with others while also being self-driven, comfortable taking initiative and making decisions when needed. At the same time, you know when to seek input and expertise from subject matter experts, both internally and externally.
Education and experience requirements:
Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline.
10+ years of relevant biopharmaceutical industry experience, including significant roles in QA process development, manufacturing and validation.
Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages.
Strong knowledge and experience of biotech and aseptic manufacturing.
Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation.
Strong experience managing external partners and CDMOs/CMOs.
Strong experience of Authority inspections as presenter and/or coordinator (FDA, EMA and other markets).
Strong communication, and interpersonal skills with the ability to influence across functions and levels.
Strong problem-solving skills and a hands-on, execution-oriented mindset.
Our culture and values
Working at Hansa is more than a job for us, and our culture is characterised by pride β pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world.
For best cultural fit we assume you share our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day.
We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve.
Why Join
In this position you will contribute to life changing outcomes for patients with acute or serious immune mediated conditions.
You will be part of an innovative R&D-driven organisation with a strong desire to make a difference for people and also be part in building a fully integrated biopharmaceutical company with global outreach.
You will become part of a mid-sized company with open-minded, motivated colleagues and a truly welcoming atmosphere. At Hansa, we face challenges together and celebrate our achievements as a team.
Appealing?
Please send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.
About Hansa
Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders.
Our broad therapeutic pipeline based on the companyβs proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people, we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.