qa manager, lund

Job description
Come join Camurus as their new QA Manager! 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. As a QA Manager, you will work closely with your colleagues and support the various clinical teams with your expert knowledge and you will work in accordance to ICH GCP, Camurus SOPs and local regulations. The company is in a very active phase, with several studies in phase III, as well as trials in earlier development phase, ongoing or under planning. Therefore Camurus is strengthening the Quality Unit with a QA Manager with clinical trial experience. Don´t miss the chance to be part of an expansive research-based pharmaceutical company committed to develop and commercialize innovative and long-acting medicines for the treatment of severe and chronic conditions!

Responsibilities
As a QA Manager, you support Clinical Development Programs in cross-functional sub teams. Your responsibility is to ensure quality, consistency, and integration of study data and quality objectives from trial start through close-out activities. In this role, you will collaborate with internal functions such as clinical development, regulatory, manufacturing operations and with external contacts such as CROs. Your responsibilities will include but not be limited to: 


Be a member of clinical project team and ensure quality is incorporated in clinical trials.
Closely collaborate and support our Clinical Trial Managers.
Provide input on clinical trial agreements, plans, risk assessments.
 Lead evaluation and investigation of quality events.
 Perform GCP audits at CROs, clinical service providers and investigational sites as applicable.
 Perform internal GCP audits and for other areas as applicable. 
 Participate in writing and revising or reviewing and approving Standard Operating Procedures.
 Contribute to Development Program CMC sub-teams with focus on IMP supply, labelling etc.  


Qualifications
 Academic degree within Life/Health Science or work experience that we consider equivalent.
 Minimum of 4 years’ experience as Clinical Trial Program Manager, Clinical Research Associate, Monitor or similar.
 Minimum of 2 years’ experience as QA Manager within the GCP area.
 Experience in leading external audits.
 Knowledge of ICH GCP guidelines and applicable local regulations.
 Very good knowledge in oral and written English.  


Along with experience and knowledge of internal audits and handling external service providers, such as clinical CROs, we will be extra eager to meet you if you also have knowledge of:
 Applicable international GMP.
 GLP standards and guidelines.
 GDPR.
 Qualification/validation of IT systems used in clinical trials.

To be successful in this position you must  have a great interest in quality and be structured and organized to be able to take on many tasks at the same time. You also need to be flexible to switch between tasks and collaborate cross-functional. We would like you to be strong in both oral and written communication and fluent in English. Knowledge of Swedish is seen as an advantage. 

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Please apply no later than 2021-11-07 via www.randstad.se. Selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible. In this recruitment process we collaborate with Randstad Life Sciences. For more information: Contact Recruitment consultant Emelie Lanner at emelie.lanner@randstad.se. 

About the company
Camurus is a 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 www.camurus.com.