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Quality Assurance Manager - Camurus AB

Camurus is Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal ® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit camurus.com.

You will report to the Head of Quality and be part of the QA team and take the role as Responsible Person (RP) for the wholesale activities. You will be working with GDP/GMP tasks for commercial products and clinical supplies. You will work in a deadline driven and fast-paced, international environment requiring a high level of flexibility and responsiveness.

As Quality Assurance Manager you will be working with handling of complaints, and recalls as well as handling of deviations, CAPAs and Change Requests. You will lead internal audits according to GMP/GDP guidelines, external audits of distributors according to GDP guidelines and manage quality agreements with distributors. Furthermore, you will participate in qualification of vendors and prepare relevant SOPs. You will also support with statistics and documents for Product Quality Review and Management Review meetings. You will interact closely with Camurus’ Technical Operations, Regulatory and commercial organizations to set up and maintain distribution and related quality activities in new and established markets.

In addition, you will support the R&D organization with for instance review of instructions, analytical methods, qualifications/validation documents from laboratories and laboratory data and ensure authorization of SOPs for research and GMP laboratories.

Candidate profile

To be successful in this position, you have a MSc in Pharmacy or equivalent. You have minimum five years of experience in a similar role in a pharmaceutical company with documented GDP training and ideally experience from the RP role. You have documented internal and external auditing experience. You have some experience and understanding from pharmaceutical production (GMP) and Quality Control Laboratories (GMP) or Development Laboratories.

You have a strong understanding of quality assurances processes and methods. You have excellent communication and collaborative skills with a proven track record of building and developing effective relationships with stakeholders.

You have an excellent command of both oral and written English and Swedish and preferably a moderate level of German, French or Spanish. Your work approach is structured, systematic and organized and you are quality minded and conscientious. You have a proactive way of working and thrive in a fast-paced and dynamic environment and are a resourceful team player, with the ability to also work independently.

The opportunity for you

This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers a combination of local and international work environment and corporate culture, with the possibility for individual development and growth.

Camurus has approximately 100 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership by everyone, quality, and passion about realizing our ideas and goals.

The application process is ongoing, so apply as soon as possible but no later than 30th of April. In this recruitment we are working with K2 Search as our recruitment agency. Please contact Senior Consultant Arne Nordström, +46 70 6989200 or Research Consultant Linnea Lindroth, +46 765 253859 for more information. All information with be handled with strict confidentiality.