Responsible Person/Sr Manager QA

Om jobbet

A high-impact role where you take ownership of QA across the Nordics and help shape the future of leading self-care brands. Ready to make your mark?

Location:Sundbyberg, Stockholm - with flexible remote work options

Department:Healthcare

Reports to:Senior Regulatory Affairs Manager

Do you want to influence the quality behind some of the strongest self-care brands in the Nordics?

Conaxess Trade is one of the leading Sales, Marketing and Distribution companies in the Nordics. This company works with several well-known self-care products, such as Treo, Zyx, VårtFri and Linicin - and the vision is simple: We make brands more successful!

As a small company working with major brands, Conaxess Trade Sweden offers a dynamic environment where you will work close to the business and influence both processes and ways of working.

In this recruitment process, Conaxess is once again partnering with PharmaRelations, where we are looking for aResponsible Person/Senior Manager Quality Assurancewho wants to take full responsibility for quality work within the Healthcare segment across the Nordics.

The Role

In this central and broad position, you are responsible for all quality-related work within Healthcare in the Nordics and also act as Responsible Person for our wholesale license. You collaborate closely with Brand Owners, Supply Chain, Regulatory Affairs, Marketing and Sales - and serve as the primary point of contact for quality matters. You will play a key role in developing and ensuring robust, pragmatic and business-oriented quality processes. In Finland, a local RP reports to you.

Main Responsibilities

Quality Management System & GDP

• Ensure an updated and compliant QMS.
• Conduct and lead quality and compliance trainings.
• Perform yearly GDP training.
• Manage annual activities such as management reviews, mock recalls and self-inspections.

Quality Assurance Work

• Investigate deviations and lead change controls.
• Create and implement CAPAs.
• Qualify suppliers and customers.
• Manage out-of-stock situations across the Nordics.
• Support the supply team regarding temperature deviations, documentation issues, etc.
• Build robust procedures for complaints handling and complaints sample requests by CMO.

Cross-Functional Support

• Collaborate with Sales & Marketing on customer listings.
• Manage various quality-related requests from MAH, manufacturers and CMOs.
• Participate in regulatory and quality processes, including communication with Nordic authorities.

Documentation Management

• Ensure structured and up-to-date agreements, correspondence and documents.
• Ensure that all files are up-to-date and easily accessible within the company's document management system.
• Contribute to clear and easy-to-understand SOPs.

Qualifications

Experience:

• Minimum 10 years of QA experience within the pharmaceutical industry.
• Excellent knowledge of GDP, GMP and ISO.
• Qualification to act as RP - RP or deputy RP experience is an advantage
• Fluent in Swedish and high proficiency in English.
• Experience from OTC/FMCG are meriting.

Competencies:

• Detail-oriented with strong ability to manage multiple processes simultaneously.
• Excellent communication and organizational skills.
• Ability to work effectively under deadlines and within a cross-functional team environment.
• Strong understanding of the commercial importance and business development related to quality.
• Proficiency in MS Office.
• A humble, solution-oriented and business-minded approach.

Education:

• Master's degree in pharmacy, life science or equivalent.
• Additional qualifications or certifications in quality assurance.

Performance Indicators:

• Overall business results dependent on Quality Assurance.
• Accuracy and timeliness of quality supporting work.
• Effectiveness in supporting supply with quality compliance activities.
• Contribution to maintaining and updating QMS and training.
• On time assessment of deviation investigation and closing CAPAs.
• Positive feedback from cross-functional teams on quality support provided

What We Offer

• A key role in a company with speed, short decision paths and strong team spirit.
• The possibility to influence and develop quality work across the Nordics.
• A workplace offering variation, responsibility and close collaboration across teams.

Want to make a difference?Join Conaxess Trade Sweden and you will be part of an engaged team where quality and business go hand in hand.

The next step

If you you have the experience and qualifications we are looking for, please either apply to the position 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. Interviews are already taking place, so please get in touch or apply at your earliest convenience.