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QA & RA Manager

AGB-Pharma is a fast-growing, international pharmaceutical company, located in Medicon Valley in Lund.

The company was the first pharmaceutical company in Europe to receive approval for treatment with the sleep hormone melatonin for children with ADHD and sleep disorders. Sleep disorders in children with neuropsychiatric disabilities are a very fast growing market segment. In 2021, AGB-Pharma had sales of more than SEK 166 million with products in Sweden, Norway and Denmark. In April 2022, Adaflex® (melatonin) was launched in the UK and more European markets await in the future. AGB-Pharma can be described as a niche pharmaceutical company, with a focus on sleep health and with scientific and medical excellence in the field of melatonin. The company has advanced pipeline projects to further broaden the product portfolio. Here you are part of an experienced and competent team of about 20 employeese, all at a high senior level of knowledge about the company’s specific product portfolio. The team has short decision-making processes where each employee’s contribution is important for the company’s development and results.

On behalf of AGB-Pharma, PharmaRelations is recruiting the next colleague to the team – a QA & RA Manager. This is a full-time permanent hybrid position. The position is preferably based in the office in Lund, but for the right person, alternatives can be discussed. You report to the company’s RA Director.

Responsibilities within QA:

Implement and maintain a quality management system demonstrating GDP and GMP compliance with international regulations/standards
Issue, review and approve Standard Operation Procedures (SOP)
Ensure initial and continuous training are implemented and maintained
Participate in any recall operations
Ensure that relevant customer complaints are dealt with effectively
Ensure that self-inspections are performed necessary corrective measures are put in place
Ensuring that any additional requirements imposed on certain products by national law are adhered to
Serialization: Perform various steps in SSM and TraceLink
Evaluate and assess annual Product Quality Review
Responsible for CAPA and deviation processes
Audit Suppliers

Responsibilities within RA:

Manage the core and local regulatory dossiers, life cycle management and compilation of submissions for medicinal products
Design and implement regulatory strategies & deliverables in alignment with the overarching regulatory strategy and region-specific requirements and develop risk assessment of the project(s)
Creation and/or review of regulatory documentation relevant for submission
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
Provide regulatory input to cross functional teams/projects
Co-ordinating subsidiaries, partners, and consultants on applicable market(s)
Regulatory project lead when relevant
Product Information – ensuring creation, revision, and translations to local languages
Experience from working in various databases (XEVMPD, fass.se, Felleskatalogen, LiiV etc.)
Primary interface with local health authorities
Assess scientific data provided by specialist for registration purposes against EU regulatory requirements, identifying gaps and developing mitigation strategies
Maintain an active awareness of EU legislation and assess its impact on AGB. Develop and execute strategies to respond to those
Experience of various procedures (NP, DCP and MRP)

Personal characteristics:

Solution-oriented and flexible in mindset and being able to challenge status quo
Good at calibrating standards of work and seeing the big picture, not getting stuck in details
Ability to independently organising, sequencing, prioritising and carry out given tasks including decision making as necessary
Openminded and appreciative towards an evolving and dynamic workplace where cross-functional collaboration and own initiatives are key
Ability to work independently with minimal supervision
Relationship/experience of regulatory authorities
Communicative (written and verbally), collaborative and structured
Generous about sharing knowledge and ideas
Care for the wellbeing of our colleagues and end-users of our products

Competence profile:

Degree in pharmacy, biology, chemistry, pharmacology, or related life science
At least 3 years’ but preferable solid experience from life science industry and from managing quality systems within GDP or GMP
Experienced Microsoft Office user
Adequate understanding of Artwork maintenance and associated label requirements
Languages: English and Swedish fluent in speech and writing
Certified or experienced auditor

Why AGB-Pharma?

The team at AGB-Pharma have many years of experience in the pharmaceutical industry, with specific expertise in the company’s various areas: Quality, Regulatory, Production, R&D, Supply Chain, Medical, Marketing and Sales. You will have a lot of personal responsibility, and it is an advantage if you feel confident that you have the experience required to take that responsibility. As AGB-Pharma is a start-up company, it is sometimes required that you can put the infrastructure in place to be able to implement your plans.

Last but not least:

Fast-growing Swedish pharmaceutical company with headquarters in Lund and Swedish owners
Fresh premises in attractive Medicon Village with about 100 other Life Science companies
Appeared on the market for a few years, almost a start-up company with an entrepreneurial spirit
Many experts and knowledgeable colleagues in the field
1 product registered in many different markets i.e., many different partnerships and contacts within the government
Tho company plans to expand in other markets and indications
You will find community, team spirit, development opportunities. For us, it is important that you enjoy and have fun at work!
Do you want a position where you contribute daily to solutions for children with sleep difficulties and for young people with ADHD? AGB-Pharma now facilitates the treatment of sleep disorders with its first, registered drug for insomnia in children and adolescents (6–17 years) with ADHD
Turnover> SEK 200 million after 2 years on the market

Application

If you believe you have the experience and qualities we are looking for, please either apply here with a complete application (motivation letter, CV) or contact Kristina Edholm for a confidential discussion (kristina.edholm@pharmarelations.se). Please do not submit any documents via email due to GDPR reasons. Interviews are taking place, so please get in touch or apply at your earliest convenience.

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