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 was founded in 1981, 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 www.camurus.com

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QA Manager, GCP


Company: Camurus AB
Position: QA Manager GCP
Reports to: Quality Director, Quality Unit
Residence: Preferably Öresund region
Location: Ideon Science Park in Lund, Sweden


The position as QA Manager GCP

This is an exciting new position at Camurus. The role as QA Manager GCP involves close interactions with Clinical Development & PV, Regulatory Affairs, CMC RA, Manufacturing Operations, and other internal stakeholders as well as external support organizations e.g., consultants and partners at an international level.

You will strengthen the Quality Unit with your knowledge in GCP practices and regulations and their interpretations to assure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures. As our QA Manager GCP, you will contribute to our Clinical Development Program sub-teams and provide sponsor quality oversight of GCP activities in the planning phase, during and at closing of clinical trials. You will identify and attend to quality and compliance issues both internally and with external (CRO) counter parts. Where relevant review and/or approve clinical CRO quality agreements, quality related trial plans, vendor qualifications, quality events/incidents and CAPAs, and participate in establishing quality metrics, risk assessments etc.

You will plan, perform, and follow up on audits of GCP vendors and clinical CROs. As sponsor representative oversee audits of CRO IT systems, clinical sites, and other related service providers to assure the activities follows Camurus QMS, global GCP regulations and SOPs. In addition, you will oversee that our QMS, processes and activities are fit for purpose and GCP compliant. You will also perform internal audits for GCP and as applicable other regulatory areas to assess that our processes are implemented.

As a member of the CMC sub-teams, you will support internal/external activities related to the IMP supply for our clinical trials. Other quality activities e.g., review, write, approve, and implement SOPs, manage change controls, deviations and CAPAs 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:

• Participation in Clinical Development Programs sub-teams to ensure quality, consistency, and integration of study data and quality objectives from trial start through close-out activities:
- Support Clinical Trial/Outsourcing Manager for clinical CRO services by e.g.
- Review and evaluation of selection documentation for CROs and vendors for e.g., TMF, data management
- Preparation and/or review and/or approval of e.g., study related plans, agreements, risk assessments, pharmacy manual

• Participate in Development Program CMC sub-teams

• Support activities related to IMP supply for clinical trials according to protocol, SOPs, ICH GCP Guideline, GMP and regulatory requirements through e.g.:
- Review/approval of master label
- Evaluation and approval of temperature excursion
- Preparation and/or review and/or approval of e.g., statement, CoA
- Review of master service agreement, work orders, quality agreements
- Review of packaging batch records

• Review, write, approve, and implement SOPs

• Where applicable, review of IMP manufacturing, labelling, packaging CMO documents:
- Quality agreements
- Change controls, deviations and CAPAs
- Interact with external QPs

• Perform GCP audits at CROs, vendors

• Perform internal audits within GCP and other areas as applicable

• Provide guidance in GCP guidelines


Experience and qualifications

• Academic degree within Life/Health Science
• Thorough knowledge of all aspects of the clinical trial process
• Previous experience as QA Manager within GCP area
• Experience of managing external GCP service provider
• Knowledge of global GCP regulations
• Lead auditor/co-auditor experience within GCP
• Experience of IT system such as eTMF, EDC, eCRF, IWRS, Systems for risk management and the requirements for validation of IT systems is an advantage
• Knowledge of GMP is an advantage
• Experienced user of MS Office package
• Fluent in oral and written English


Required skills and personal characteristics

• Excellent oral and written communication skills and ability to adjust communication to different target groups
• A structured, systematic, and an organized way of working
• Manage different projects at the same time and work independently as well as in team and cross functional
• Can think strategically in order to improve our current processes and ways of working
• Adapts to changing circumstances and works productively in a high-pressure environment
• Demonstrates integrity


Other

The position as QA Manager GCP will be based in Lund with flexibility to work from home. You will be part of a dedicated team of 5 people within the Quality Unit group and report to Quality Director.


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 www.peaksearch.se