Camurus is 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.
Camurus is a knowledge-based company, and the know-how, innovation, and expertise of our employees is an essential part of our continued success. Passion, knowledge, and creativity are vital for attaining our goal: to offer patients and society new and improved treatments for serious and chronic diseases. The vast majority of Camurus’ employees work in research and development and many of them hold advanced university degrees. Our business and comprehensive expertise are continually developed through an active transfer of knowledge throughout our international network and through intense collaborations with academia and industrial partners.
Our development create value across the pharmaceutical development cycle, from early programs to partnerships with international pharmaceutical companies. To maximize the value creation for our products, we are building our own European commercial organization with an initial focus on the opioid dependence market and other specialty markets with suitable dynamics and a concentrated prescriber base.
Camurus had a productive year during 2021 with increasing revenues, new regulatory approvals, progress in the development portfolio, and the publication of strong data in leading scientific journals. The company is in an expansive phase and has today about 160 employees, in addition, many consultants and contract companies are used. Camurus has its HQ in Ideon Science Park in Lund and is listed on Nasdaq Stockholm.
For further information about Camurus, please visit the company's website http://www.camurus.com.
QA Manager, GDP
Company: Camurus AB
Position: QA Manager GDP
Reports to: Director Quality Operations and RP
Residence: Preferably Öresund region
Location: Ideon Science Park in Lund, Sweden
The position as QA Manager GDP
Camurus is searching for a QA Manager GDP to join the Quality Operations team with focus on quality management for the commercial production and distribution of approved and launched products. We are looking for a communicative and collaborative person with interest and competence in Quality Assurance and experience in Good Distribution Practice (GDP) and/or Good Manufacturing Practice (GMP).
The overall focus of the role is to ensure the compliance of all activities in accordance with company global standards, country regulations, and registered information. Manufacturing, packaging, and distribution are outsourced activities to third part CMOs and other vendors.
The role offers a variety of tasks, including:
• Development and maintenance of Camurus’ Quality Management System (QMS)
• Interaction with internal and external stakeholders
• Review of quality agreements
• Handling of complaints, deviations, risk management and change control
• Internal and external audits
• Qualification of suppliers and customers
• Participation in PQR creation
This is an exciting new position at Camurus. The role as QA Manager GDP involves close interactions with CMOs, distributors, and other external partners as well as internal stakeholders, e.g Supply, Pharmacovigilance, Medical Affairs and Camurus’ local entities, all at an international level.
As our QA Manager GDP, you will identify and attend to quality and compliance issues both internally and with external counter parts, e.g review of quality agreements, vendor qualifications, quality events/incidents, manage complaints, deviations and CAPAs.
You will plan, perform, and follow up on audits of GDP and GMP vendors. You will also perform internal audits to assess that our processes are implemented.
Other quality activities e.g. review, write, approve, and implement SOPs, and contribute to continuous improvement are also a part of the responsibilities.
All these interactions with internal and external stakeholders puts high demands on the understanding of different cultures and great diplomatic skills.
Main purpose of the job
Key responsibilities will include but not be limited to:
• Coordinate quality activities in Quality Operations
• Support Camurus’ functions and subsidiaries in QA topics
• Interact with external partners (distributors and manufacturers)
• Review GDP documents from partners (Quality Agreements, Change controls, deviations and CAPAs)
• Handling of complaints and alerts from serialization system for medicinal products
• Handling internal deviations and change controls
• Manage internal audits at Camurus/subsidiaries according to applicable guidelines and internal SOPs
• Participate in GDP audits of suppliers
• Establish and evaluate vendor/supplier questionnaires
• Write and approve SOPs and policies
• Participate in supplier and customer qualifications
• Participate in quality risk management procedures for GDP
• Prepare documents for PQR
• Support in placing goods in saleable stock, with returns and destructions
Experience and qualifications
• Academic degree within life science or pharmacy
• Previous experience of Quality Assurance within GDP from pharmaceutical/biotech industry
• Experience in auditing with GDP scope
• Experience of complaint, and deviation and change management
• Knowledge of applicable international standards and guidelines for pharmaceuticals, including GDPs and national legislation for controlled substance
• Knowledge of combination products/drug device combination products is beneficial
• Qualifications to act as deputy responsible person is beneficial
• Experienced user of MS Office package
• Fluent in oral and written Swedish and English
Required skills and personal characteristics
• Work independently as well as in team and cross functional
• Excellent oral and written communication skills and ability to adjust communication to different target groups
• Organized, structured, and systematic way of working and you can manage different projects at the same time.
• Adapts to changing circumstances and works productively in a high-pressure environment
Other
The position as QA Manager GDP will be based in Lund with flexibility to work from home. You will be part of a dedicated team within the Quality Operations group and report to Director Quality Operations and RP.
Opportunities with the role
This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers an international work environment and corporate culture, with the possibility for individual development and growth.
The corporate culture is driven by innovation, strong collaboration internally and externally, ownership, quality, and passion about realizing our ideas to achieve our patient-centric vision. Camurus has all functions in place which means you will work in a broad development environment, and with products that can make a big difference for patients with severe and chronic conditions. Being part of a small organization offers high visibility, broad responsibilities, and an opportunity to make a real impact.
Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379
Application
Apply for the position at http://www.peaksearch.se