QA Manager – QMS, Complaint Handling and Training
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Join a leading and fast-growing biotech company.
Ascendis Pharma A/S is currently expanding its Quality Systems & Compliance team to be ready for commercial products on the market. This position is therefore a unique chance to join an entrepreneurial company on its growth journey and hold a key role in complaint management, handling complaint processes and establishing training in these processes.
As QA Manager, you will become responsible for complaint management and handle complaint processes regarding both marketed as well as development products. Additionally, you will drive QMS training and Quality improvement initiatives. You will join Quality Systems & Compliance consisting of dedicated specialists and report to Head of the Complaint Management & Training team. As you will be working across different sites of Ascendis Pharma and towards CMOs, you will have wide collaboration globally and manage stakeholders at all levels.
Criteria of success in the role will be to process complaints according to internal procedures and in collaboration with SMEs and CMOs. Furthermore, you will provide data trend for the complaint process and oversee follow-up activities such as CAPA’s, deviations and change controls related to the activities. The successful candidate will identify the need for knowledge and training on complaint handling and establish training programs for all roles involved in the complaint handling process.
Additionally, you will manage the oversight of the status of the CMOs’ qualification program incl. certificates. Further, you will have the opportunity for working on quality system activities and projects within the project portfolio.
Main areas of responsibility:
You have minimum 3-6 years of QA experience within the life science industry. Preferably, you have experience with complaint processing of either drugs, medical devices and/or drug-device combination products as well as with implementing and maintaining both processes and associated trainings in a Quality Management System in a GxP environment. Furthermore, you are competent within stakeholder management, and have a good business understanding.
You have a master’s degree, preferably in Natural Science. You are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a highly motivated and self-driven individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as you will be working across different sites of Ascendis Pharma and have a significant role in the organisation. You are a pragmatic person with an open and communicative approach that is inspired to find new and smart ways to fulfil quality requirements.
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Partner, Rasmus Meyhoff or Research Manager, Pernille Hemmingsen on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany and Palo Alto, California. For further information, please see
www.ascendispharma.com.
Deadline for application: As soon as possibleWorkplace: Hellerup
Company: Ascendis Pharma A/S
Reference: 2205.052
QA Manager - QMS, Complaint Handling and Training
Ascendis Pharma A/S
Join a leading and fast-growing biotech company.
Ascendis Pharma A/S is currently expanding its Quality Systems & Compliance team to be ready for commercial products on the market. This position is therefore a unique chance to join an entrepreneurial company on its growth journey and hold a key role in complaint management, handling complaint processes and establishing training in these processes.
Complaint Management and Quality improvement
As QA Manager, you will become responsible for complaint management and handle complaint processes regarding both marketed as well as development products. Additionally, you will drive QMS training and Quality improvement initiatives. You will join Quality Systems & Compliance consisting of dedicated specialists and report to Head of the Complaint Management & Training team. As you will be working across different sites of Ascendis Pharma and towards CMOs, you will have wide collaboration globally and manage stakeholders at all levels.
Criteria of success in the role will be to process complaints according to internal procedures and in collaboration with SMEs and CMOs. Furthermore, you will provide data trend for the complaint process and oversee follow-up activities such as CAPA’s, deviations and change controls related to the activities. The successful candidate will identify the need for knowledge and training on complaint handling and establish training programs for all roles involved in the complaint handling process.
Additionally, you will manage the oversight of the status of the CMOs’ qualification program incl. certificates. Further, you will have the opportunity for working on quality system activities and projects within the project portfolio.
Main areas of responsibility:
- Complaint management, incl. support
- Build and perform training in the complaint management process and support the training process in general
- Drive improvement initiatives across the organisation
- Oversee and update approved supplier list
Self-driven QA Manager with Complaint Management experience
You have minimum 3-6 years of QA experience within the life science industry. Preferably, you have experience with complaint processing of either drugs, medical devices and/or drug-device combination products as well as with implementing and maintaining both processes and associated trainings in a Quality Management System in a GxP environment. Furthermore, you are competent within stakeholder management, and have a good business understanding.
You have a master’s degree, preferably in Natural Science. You are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a highly motivated and self-driven individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as you will be working across different sites of Ascendis Pharma and have a significant role in the organisation. You are a pragmatic person with an open and communicative approach that is inspired to find new and smart ways to fulfil quality requirements.
Apply now
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Partner, Rasmus Meyhoff or Research Manager, Pernille Hemmingsen on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
About Ascendis Pharma
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany and Palo Alto, California. For further information, please see
www.ascendispharma.com.
Deadline for application: As soon as possibleWorkplace: Hellerup
Company: Ascendis Pharma A/S
Reference: 2205.052
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 9.2.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Hellerup
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