QA Director - Inspection Management
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Feb 24, 2021
Last Date
Mar 24, 2021
Location(s)

Job Description

Join a leading and fast-growing biopharmaceutical company in central Copenhagen.

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 Director of Inspections and Compliance, your main success criteria is to lead inspections and compliance programs, drive inspection readiness and follow up across the organization in a global context. You will be responsible for the self-inspection program internally and for our outsourced activities. Additionally, you will also oversee relevant quality performance monitoring across Ascendis Pharma and be accountable for strategic direction for the area.

You will be part of the Ascendis Pharma QMS and Compliance team and be an active participant on a very exciting journey towards establishing a superior biotech quality organization.

Your main responsibilities are:

  • Ownership of the health authority inspection process and the internal self-inspection program
  • Drive 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 continous regulatory compliance risk assessements
  • Seek influence in relevant networks and industry organizations

You have solid experience with inspections and preparing organizations for a successful inspection outcome. You want to work centrally in the quality system processes, support submissions and lead regulatory authority inspections. You hold a relevant degree within e.g. Pharmacy, Biology, Biochemistry, Chemistry. However, most important is your experience with inspections and audits, QMS, global regulations, and your ability to drive processes involving many global stakeholders.

The successful applicant will have a proven track record with inspections management and solid experience working with Quality Management Systems driving global compliance in an international pharma, biotech or medical device environment.

The following qualifications are desirable:

  • A minimum of 10 15 years experience within quality and solid experience with inspections and audits
  • Indepth understanding of the manufacturing processes as well as excessive knowledge and application of global regulations and guidelines in relation to biotech and pharma industry
  • Extensive experience in licensure of products, facilities, and global compliance including prior approval or prior licensure inspections and cGMP inspections
  • Experience with large stakeholder management and metrics reporting to senior management teams

You are proficient in English at a professional level, both written and spoken. You have excellent presentation skills and are familiar with presenting to authorities and to stakeholders at all levels and functions of the company.

You are a pragmatic person with an open and communicative approach, and you have the ability to develop effective working relationships with employees at all levels, and you enjoy being in a position with an international reach. You are flexible, persistent, and resourceful.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.

Travelling: Approx. 20-30 days/year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.

For more details about the job or the company, please contact Senior Director Lars Dreiøe at or at +45 50899525. All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

Information Technology and Services - San Jose, United States
© Copyright 2004-2024 Mustakbil.com All Right Reserved.