CMC Quality Assurance Manager

at  Hansa Biopharma

WOULD YOU LIKE TO BE PART OF A GROWING BIOPHARMA COMPANY?

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 rare immunological conditions.
Our broad therapeutic pipeline based on the company’s 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 and working in an agile way 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.
Position: CMC Quality Assurance Manager
We are looking for a CMC quality assurance manager with extensive experience in quality work that is related to maintaining GMP compliance for commercial product(s) and development and GMP production of novel biologicals.
You enjoy engaging with CMC activities and have broad experience with biological products and want to be part of the quality assurance of products used to treat severe IgG-driven diseases, improving patient’ health and well-being.
Hansa Biopharma has an agile project-oriented workflow, and the skills and initiatives of each team member are vital for advancing projects. You will report to the Senior Director CMC Operations at Hansa Biopharma.

PROFESSIONAL QUALIFICATIONS

To succeed in this position, we believe that you should have the following background and experience:

• A Ph.D in one of the following areas: Biochemistry, Biotechnology, Chemistry or Medicine
• More than 5 years of experience in quality assurance in drug development and commercial manufacturing in the biopharmaceutical industry
• Solid GMP-regulated experience working in GMP quality systems and with drug substances and drug products; clinical and commercial experience in a GMP environment is required

• Experience interacting with the FDA, EMA and other global health authoritiesExcellent verbal and written communication and presentation skills in English, preferably also in Swedish

PRINCIPAL RESPONSIBILITIES

• Provide support to the CMC Department in Good Manufacturing Practices (GMPs) with significant operational and quality experience
• Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s and CMOs
• Drive process and product quality through CMC quality systems, ensuring adequate supplier oversight/surveillance
• Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling
• Participate in contracts with external parties such as CMOs, CROs, and consultants
• Provide strategic planning input and continual improvement measures focused on records processes, reporting/escalating critical quality issues
• Document and initiate change control, perform quality investigation reports in Hansa´s quality management system
• Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality
• Manage, maintain, and continuously improve the batch review process as a facilitator for Quality Assurance in product teams
• Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to quality and error reduction
• Encourage an environment for ‘Quality Right First Time’ by building in efficiencies as necessary from a systematic and compliance perspectivePerform additional quality-related duties as assigned by Director CMC Operations

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

• Comfortable in taking responsibility and enjoy taking initiative
• Ability to drive collaboration with vendors, and external and internal parties
• Creative mind with ability in solution-oriented analytical thinking
• Thriving in fast moving project environment, enjoy challenging tasks with tight deadlines
• Comfortable in small company setup and work outside your expertise area when neede