Iconovo develops ready-to-use inhalation products – inhaler devices and dry powder formulations for generic drug companies and pharmaceutical companies. Iconovo offers a full range of ready-to-use inhalation devices to be customized with customer’s substance
Products developed by Iconovo are mainly in the treatment of asthma and COPD, but other focus areas are vaccination, pulmonary hypertension, pulmonary fibrosis or indications where a fast onset of action is sought, e.g. migraine treatment. Today the company portfolio covers a full family of inhalation products comprising both inhalation devices and dry powder formulations.
Business model: Iconovo develops the inhaler platforms at its own cost and risk and seeks patent protection for its unique designs. Iconovo develops a complete inhalation product from its customers preferred substance(s) being compensated for the development costs through development milestones. Iconovo makes its profit from technology access fees for giving exclusive rights to a substance-inhaler combination and royalties on sales.
The company was founded in 2013, listed on Nasdaq First North in May 2018, is based at Ideon in Lund, and employs 33 (plus consultants) people today.
For more information about Iconovo, please see http://www.iconovo.se
Manager Quality Assurance
Company: Iconovo AB
Position: Manager Quality Assurance
Reports to: CEO Iconovo
Location: Lund, Sweden
The position as Manager Quality Assurance
Iconovo develops ready-to-use inhalation devices to be customized with generic drug companies and pharmaceutical companies (customers) substance. The device is registered as a medical device; however, the complete inhalation product is registered as a drug.
For the QA function at Iconovo, this means that the responsibility is to make sure that development and production of the device is compliant with applicable quality standards and requirements (mainly MDR 2017/745, ISO 13485 and CFR part 820 (QSR). The documentation approved by a Notified Body will then be part of the final registration file, which is the responsibility of the drug company (the customer).
The Manager QA will play an important role in actively supporting the company in all QA related issues as well as act as Person Responsible for Regulatory Compliance (PRRC). The Manager QA is responsible to encourage and improve the QA mindset in the company which means you will have a broad scope of responsibilities, all related to the regulatory compliance. You will provide guidance and leadership to management and project teams regarding QA. You will be responsible for Iconovo’s Quality Management System (QMS), deliver solutions to aid compliance within the daily work and support colleagues in quality issues. The role involves close interactions with Operations, Project Management, and other internal stakeholders as well as external, e.g. consultants, customers, and partners at an international level. This puts high demands on the understanding of different cultures and great diplomatic skills.
The Manager QA has a very important function to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements. You need to be good at analyzing data and translating the outcome to actions. Furthermore, part of the role is to coordinate and support audits, conducted by external providers or authorities, both during audits and with follow-up of findings and corrective actions. In addition, you will also perform external audits, e.g. suppliers, in close collaboration with relevant stakeholders.
Today the Manager QA will be line manager for one person and most likely for one or two more people in the team, as the company grows. You will report directly to CEO and have close interactions with VP Operations.
For this role, we are looking for a highly skilled and motivated person with a solid QA background from MedTech, with a flexible mindset and ability to find solutions within given frameworks. In addition, you need to have analytical, communication (oral and written) and leadership/planning skills as well as being solution-oriented.
You must be able to make decisions and provide others with a clear direction. As a person, you are self-motivated, meticulous, have integrity, and ability to inspire others. You have a strong drive with the ability to take initiatives and work in a well-organized and structured way. Given the size of the company, you must have a “can-do attitude” and not be afraid to roll up your sleeves.
Essential tasks will include but not be limited to:
• Contribute with QA/RA knowledge regarding Medical Devices and Combination Products in projects
• Provide guidance and leadership to management and project teams regarding QA
• Develop in-house quality procedures (and templates) and keep them up-to date
• Review documents from a QA perspective, control plans and the resulting QC data
• Approve -
o procedures and validation / qualification reports applicable to Design Verification
o change requests
o goods for verification or clinical trial
• Work with operating staff to establish procedures, instructions, and other relevant documents
• Support development of supplier quality agreements and approve the agreements
• Plan, perform and follow up external audits in close collaboration with stakeholders, and supplier audits
• Take part in preparation of and attend Management Review meetings
• Train new staff in relevant parts of the QMS and ensure training is held at major updates of QMS documents
• Participate in customer projects regarding QA issues
• Be the contact person for customer regarding quality issues
• Responsible for the staff's further development
• Work in compliance with Iconovo QMS and applicable regulations, standards, and guidance’s
• Responsible for conformance of Iconovo’s QMS to applicable regulations, standards and guidelines as defined in the Quality Manual (mainly MDR 2017/745, ISO 13485 and CFR part 820 (QSR))
• Responsible for ensuring that internal audit programs are being developed
• Responsible for QA aspects of nonconformity, complaint handling, CAPA and change control
• Act as Person Responsible for Regulatory Compliance (PRRC)*
• Release Iconovo products to clinical studies as Medical Devices (person responsible for regulatory compliance)
*Person responsible for regulatory compliance (according to MDR (EU) 2017/745 articel15)
The requisite expertise shall be demonstrated by either of the following qualifications:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Experience and qualifications
• Academic degree in Chemistry, Pharmaceutical Science, Engineering, or similar discipline, or other equivalent education
• Experience in medical device development
• Experience in quality management and regulatory affairs (preferably), relating to medical devices
• Experience in set up and review of Quality Management Systems
• Fluent in English, orally and in writing
• Basic Swedish
• Experienced user of MS Office package
Required skills and personal characteristics
• Makes prompt, clear decisions which may involve tough choices or considered risks
• Gains clear agreement and commitment from others by persuading, convincing and negotiating; strong argumentation skills to convince but also good listener to explore customers’ needs
• Uses technology to achieve work objectives. Ability to translate and communicate QA requirements to all staff.
• Sets high standards for quality and quantity, works in a systematic, methodical and orderly way
• Adapts to changing circumstances and works productively in a high-demanding environment
The position as Manager QA will be based in Lund with some flexibility to work from home.
Opportunities with the role
This is an opportunity to work in a rapidly growing company listed on Nasdaq Stockholm, with short decision-making processes where each employee's contribution is important for the company's development and results. You will play an important role in actively supporting the company to reach agreed milestones. The Manager QA is a new permanent position meaning you will have the opportunity to further develop the role.
Iconovo offers clever and reliable products for people suffering from respiratory and other diseases to help them manage their disease and restore health. The company is rapidly growing with currently 33 employees (plus consultants). The plan is to continue to grow responsibly with focus on capitalizing on their strategic assets.
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment Consultants at PeakSearch.
M: +46 706 152 772
M: +46 701 725 379
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, see above.