Senior PV Quality Manager, Ascendis Pharma
13 hours ago
The Company
Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is 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 their core values of patients, science, and passion, Ascendis Pharma uses their TransCon drug development platform to fulfill their mission of developing new and potentially best-in-class therapies. The company continues to expand into additional therapeutic areas to address unmet patient needs. Headquartered in Copenhagen, Denmark, in a wonderful office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea. The company has offices in Heidelberg, Germany and California, US. For more information about Ascendis Pharma, read more: ascendispharma.com .
Ascendis Pharma A/S is growing, and on behalf of our client, Best Talent is now searching for a Senior PV Quality Manager to join the group in a new position. To learn more about Best Talent, please visit besttalent.dk .
Senior PV Quality Manager
Join the GVP Quality team in a fast-growing biopharmaceutical company with a strong pipeline
- Exciting opportunity in a global team headquartered in Hellerup, DK
- Interesting and important cross-functional collaborations
- You join a well-functioning group where you play an important role with your personality and competences
- You are positive, see opportunities, and get things done
The Team
You will be joining a growing and dynamic GVP Quality team, which is a part of the QA Development team with around 30 dedicated colleagues located in Hellerup, Denmark and Palo Alto, USA respectively. This role is placed in Hellerup. The GVP team will take part in the oversight of the compliance, quality, standards, PV auditing, and training for Pharmacovigilance.
The Challenge
Your primary area of responsibility will be the GVP area, including performance of GVP audits. You will maintain an up-to-date knowledge of regulatory requirements and ensure implementation of these in internal corporate procedures.
Main areas of responsibility
- Plan, perform and report on GVP audits in collaboration with GVP colleagues internally and with stakeholders e.g. related to vendor audits
- Review and analyze audit, inspection, deviation, and CAPA data to identify root cause, compliance trends and areas of exposure related to GVP
- Prepare periodic compliance metric reports and conduct non-compliance investigations
- Provide expert compliance and regulatory advice on GVP
- Author and maintain procedures owned by GVP Quality
- Support Regulatory Intelligence monitoring and assess impact and support implementation of new/updated GVP requirements on current practices and processes
- Support the planning, conduct and follow-up on regulatory inspections
- Collaborate with subject matter experts to formulate responses to inspection findings relevant to GVP
- Support quality development initiatives within the GVP area
- Perform consultation on complex aspects of GVP
- Perform the role of Quality Partner to PV Operation (US/DK) and the EU QPPV
- Support the monitoring of PV Quality systems to proactively identify risks
- Support PV vendor oversight and qualification (e.g. quality agreements and other contracts)
You can expect an attractive remuneration package, short- and long-term incentives, pension, and health insurance. You refer to Director GVP Quality.
Talent
You hold a master’s degree in a scientific discipline and have minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP. You are a GVP auditor with experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Experience with auditing of computerized systems within the GVP regulated areas and medical device experience would be an advantage. You are proficient in English at a professional level, both written and spoken.
Furthermore, criteria for success will be:
- Proven ability to make and take responsibility for decisions to meet the ever-growing and changing stringent global GVP requirements
- Strong quality mindset and attention to detail in establishing priorities, scheduling, and meeting deadlines
As a person, you are a highly motivated individual who enjoys being challenged and working in a collaborative environment. You value inter-departmental team relationships due to your excellent interpersonal, communication, analytical, and organizational skills.
Due to significant development internationally and the commercialization that takes place these years, you must expect around 30 travelling days per year.
Application
Best Talent is responsible for the recruitment process and will be handling your application on a confidential basis. Forward your application in English marked “1885/Senior PV Quality Manager” to . Read more about Ascendis Pharma on . We will interview candidates for this position on an ongoing basis, but please apply as soon as possible. You can read more about Best Talent at .
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