QA Manager – Supplier and Audit Management
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Hellerup
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Join a leading and fast-growing biotech company
Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become involved in the development and commercialization of ground-breaking therapies making a meaningful difference to patients.
As QA Manager, you will be responsible for Supplier and Audit Management and take on a lead role in establishing and maintaining a brand-new IT platform with the aim of improving Supplier and Audit Management. You will be involved in the project from A-Z, and furthermore focus on ensuring a strong collaboration between Ascendis Pharma’s network of Auditors.
You will be part of the Quality System and Compliance team and be an active participant on an exciting journey towards establishing a superior biotech quality organization.
Criteria of success in the role are to maintain oversight of evaluation and audit of the supplier and CMO landscape and support the right level of life cycle management within. This will provide you with insights in working with the self-inspection program internally and how Ascendis Pharma can apply continuous improvement of their management of all outsourced activities and control of the supplier landscape. You will collaborate closely with the network of Internal/External Lead Auditors across Ascendis Pharma and keep the QA oversight of Audit planning and the ongoing adherence and performance monitoring to the audit plans.
Your main responsibilities are:
You have minimum 5 years of QA experience within the life science industry. You have solid experience within supplier management and the audit expectations to support and prepare the organization for successful inspections. You want to work centrally with the quality system processes, with an interest in training the organization in GxP and quality mindset and by that supporting a growing quality culture. If you have experience with Veeva Vault content management platform, it is an advantage.
Furthermore, you have experience with quality metrics reporting and deriving actions as well as understand the manufacturing processes and have knowledge and application of global regulations and guidelines in relation to Biotech/Pharma and/or Device industry.
You hold a relevant master’s degree e.g., Natural Science or Engineering. Moreover, you are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a pragmatic person with an open and communicative approach. You find it important to develop effective relationships with employees at all levels, and you enjoy being in a position with an international reach. You can actively improve processes involving many stakeholders and drive a quality agenda to develop systems and collaboration across internal and external stakeholders. You are flexible, persistent, and resourceful but still act with a good sense of humour and teamwork skills to support a pleasant daily operational work environment.
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: 2205.075
QA Manager – Supplier and Audit Management
Ascendis Pharma
Join a leading and fast-growing biotech company
Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become involved in the development and commercialization of ground-breaking therapies making a meaningful difference to patients.
Supplier Management, Audit Planning and Project Management
As QA Manager, you will be responsible for Supplier and Audit Management and take on a lead role in establishing and maintaining a brand-new IT platform with the aim of improving Supplier and Audit Management. You will be involved in the project from A-Z, and furthermore focus on ensuring a strong collaboration between Ascendis Pharma’s network of Auditors.
You will be part of the Quality System and Compliance team and be an active participant on an exciting journey towards establishing a superior biotech quality organization.
Your role
Criteria of success in the role are to maintain oversight of evaluation and audit of the supplier and CMO landscape and support the right level of life cycle management within. This will provide you with insights in working with the self-inspection program internally and how Ascendis Pharma can apply continuous improvement of their management of all outsourced activities and control of the supplier landscape. You will collaborate closely with the network of Internal/External Lead Auditors across Ascendis Pharma and keep the QA oversight of Audit planning and the ongoing adherence and performance monitoring to the audit plans.
Your main responsibilities are:
- Keep oversight of the supplier landscape, audit planning, re-evaluation process and the Veeva Audit module handling internal and external audit oversight processes and the internal self-inspection program
- Become super-user of the Veeva Audit module covering both internal and external audit oversight and the Supplier Management module and linking processes
- Support the inspection readiness programs within Ascendis Pharma as well as with key CMOs in all phases of the programs – preparing, planning, execution and follow up
- Perform continuous regulatory compliance risk assessments
- Build up a network and collaborate with the Auditors at Ascendis Pharma
Experienced QA Manager with an interest in suppliers, audits, and collaboration
You have minimum 5 years of QA experience within the life science industry. You have solid experience within supplier management and the audit expectations to support and prepare the organization for successful inspections. You want to work centrally with the quality system processes, with an interest in training the organization in GxP and quality mindset and by that supporting a growing quality culture. If you have experience with Veeva Vault content management platform, it is an advantage.
Furthermore, you have experience with quality metrics reporting and deriving actions as well as understand the manufacturing processes and have knowledge and application of global regulations and guidelines in relation to Biotech/Pharma and/or Device industry.
You hold a relevant master’s degree e.g., Natural Science or Engineering. Moreover, you are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a pragmatic person with an open and communicative approach. You find it important to develop effective relationships with employees at all levels, and you enjoy being in a position with an international reach. You can actively improve processes involving many stakeholders and drive a quality agenda to develop systems and collaboration across internal and external stakeholders. You are flexible, persistent, and resourceful but still act with a good sense of humour and teamwork skills to support a pleasant daily operational work environment.
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: 2205.075
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 16.2.2022, 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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