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Senior QA Manager, QA Commercial Operations

Ascendis Pharma A/S is an international company with offices in Copenhagen, Germany, and the US.

Ascendis Pharma is building an integrated biopharmaceutical company to advance its pipeline of long–acting prodrug therapies. They employ their proprietary “TransCon” technology platform to generate therapeutics with best-in-class profiles that address large markets with significant unmet medical needs. Ascendis Pharma has a diversified and balanced high-value product pipeline, including internal programs and partnerships with market leaders.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea. Read more at www.ascendispharma.com.

Senior QA Manager, QA Commercial Operations

Visionary, Ambitious and Fast-growing Biotech Company

– Introduction of new products to be marketed
– Cooperation cross functional and with many stakeholders
– Potential to grow your professional and personal skills
– Key role in analytical testing on different manufacturing stages

The Department

QA Drug Substance team, a part of the QA Commercial Operations department, are responsible for oversight of starting materials, intermediates, and Drug Substance for commercial products. As the department is growing, they are now looking for a Senior QA Manager. You will be part of a dynamic team in a stimulating international environment, where it is expected that you like and are used to work in a role with great influence. In the position you will act as SME and you are the leading person in QA Commercial Operations for the quality oversight of analytical testing performed on the different manufacturing stages.

The Challenge

You will act in a close collaboration with several external Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma. It is expected that you find solutions and that you can think out of the box within your area of responsibility. You go through different processes to drive the area most effectively for the team and the company. The team is characterized by high quality, result orientation and speedy realizations of the goals in an entrepreneurial environment.

You are given the opportunity to put your mark on the job in a rapid growing company where you get the chance to make great results. You will be referring to the Director, QA Commercial Drug Substance.

Your key responsibilities include:

– Review and approval of documentation from CMOs, including batch records, deviations, changes, CAPAs, stability studies, etc.
– Communication with key personnel at CMOs, including international face-to-face meetings and teleconferences
– Participate in CMO evaluations and product quality reviews
– Quality oversight of analytical testing performed on different manufacturing stages and on Drug Substance/Drug Product. This oversight includes QA evaluation of analytical deviations, incl. OOS, and QA approval of analytical method validations
– Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
– Drive and take responsibility in agreed tasks and matters
– Continuously optimize work processes and the way of executing quality oversight

You will be part of a stimulating, informal, and innovative working environment, where you will interact with very skilled colleagues and partners to deliver on Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities. You are offered a professional on-boarding program and relevant training.

Talent

The role requires experience as QA for QC and preferable you also have some experience working with or within a CMO. We are also looking for a candidate with the following experiences, knowledge, and personal qualities:

– Minimum 8-10 years of experience and a master’s degree
– Experience with chemical production
– Experience with QC testing and analytical method validation
– Knowledge about Analytical Method Validation Guidelines and Regulations
– Knowledge of US and EU GMP regulations and requirements
– Working with CMOs

Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given as well as acceptance of travelling where flexibility/variation is possible.

As a person you are ambitious and pro-active and see the benefits in going the extra mile. At the same time, you are pragmatic and yet with attention to the necessary details that is required in a position like this. You communicate in a clear and persistent way with focus on expectations and requirements to quality. You always strive for smooth collaboration with your colleagues and external stakeholders.

Application

Best Talent is responsible for the recruitment proces and will be handling your application on a confidential basis. Forward your application marked ”1726/Senior QA Manager” to job@besttalent.dk. Read more about Best Talent on www.besttalent.dk and more about Ascendis Pharma on www.ascendispharma.com