International QA Director
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Holbæk
ARE YOU A DEVELOPMENT-ORIENTED AND SELF-DRIVEN TEAM PLAYER WITH EXTENSIVE EXPERIENCE FROM QUALITY MANAGEMENT OR SR.SPECIALIST WITH A STRONG BUSINESS SENSE FROM AN INTERNATIONAL ENVIRONMENT?
DO YOU SHARE OUR PASSION FOR QUALITY AND MANUFACTURING, AND WOULD YOU LIKE TO WORK IN A FLEXIBLE AND INTERNATIONAL WORKING ENVIRONMENT, IN A GROWING PHARMACEUTICAL COMPANY?
IF NOW IS THE TIME TO MOVE ON – WE WOULD LIKE TO HEAR FROM YOU!
You will join a family-owned, international pharmaceuticals company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use. You’ll be a part of a research-based company that focuses on improving the lives of patients with iron deficiency with or without anaemia. With subsidiaries around the world, you’ll join an international and highly dynamic work environment, at their state-of-the-art site in Holbæk (with the possibility of working remotely some of the time). Currently, we are a small, but dedicated team of 3 highly experienced International QA Directors, and we look forward to welcome you, to our team. We work closely together with our colleagues in Regulatory Affairs, Supply Chain, QA and Clinical, as well as with our external Partners and Contract Manufacturers. We are driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, in a fun and flexible working environment and friendly atmosphere.
As our new International QA Director, you will have an independent role with a wide range of operational tasks and responsibilities in a challenging position that offers broad responsibility, significant influence and high independence. With your thorough understanding of customer needs, and your strong understanding of quality processes, you want to challenge the status quo when making decisions on quality management. As a member of the GMP steering committee and quality management, you want to set a clear direction that inspires for continuous development. The position will be a part of a team bringing a new drug to the market from early clinical trials to a fully commercialized product.
Your primary responsibility will be to secure efficient handling of all quality matters as well as auditing CMOs related to outsourced manufacturing activities. You will be challenging current setups and optimizing established processes. Effective communication is key, as you will be responsible for creating strong relationships and handling continuous dialogues, presenting complex ideas and explaining them clearly to both internal and external stakeholders at all levels. As International QA Director you will ensure that the company’s external and outsourced activities comply with the company’s own requirements, applicable rules for good manufacturing and distribution practice (GMP and GDP) and other applicable rules.
The International QA Director reports to the VP for Quality and Regulatory Affairs.
You will make sure that the quality is current and maintained with all CMOs, vendors, subsidiaries and partners with the primary focus on aseptic and sterile contract manufacture. You will conduct surveillance and audits of the contract manufactures and packaging sites; ensuring compliance with the agreed terms specified in the quality agreement (technical agreement), cGMP and GDP. You will ensure that all existing legislation is implemented in all relevant external collaborations. By participating in technology transfers between external stakeholders to supervising development projects and auditing both CMOs, distributors and vendors, you are guaranteed a developing job, both professionally and personally, within International Quality.
You have a MSc level education (or higher) in Pharmacy or a similar field and +10 year of experience as a QA Manager/Director or Sr. Specialist (this combined with production experience would be an advantage). Preferably you also have a few years of experience with international project management. You want a role that offers flexibility, while providing you with strong ownership of your areas of responsibility.
In addition, we expect you to:
An independent and influential function in global settings, with a broad range of tasks and responsibilities. An opportunity to join a small and dedicated team with an open and friendly atmosphere. A large number of talented and dedicated colleagues across functional disciplines. Inspiring and flexible working environment. An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth. An attractive and competitive compensation package.
20-25 days a year
Black Swan Exist, Daniel Hede Olsen, is responsible for the recruitment process on behalf of Pharmacosmos A/S. You can get more information about the job by calling Daniel +45 3160 9381. You can also click on the blue button in the top right and send an e-mail to Daniel.
DO YOU SHARE OUR PASSION FOR QUALITY AND MANUFACTURING, AND WOULD YOU LIKE TO WORK IN A FLEXIBLE AND INTERNATIONAL WORKING ENVIRONMENT, IN A GROWING PHARMACEUTICAL COMPANY?
IF NOW IS THE TIME TO MOVE ON – WE WOULD LIKE TO HEAR FROM YOU!
about the team
You will join a family-owned, international pharmaceuticals company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use. You’ll be a part of a research-based company that focuses on improving the lives of patients with iron deficiency with or without anaemia. With subsidiaries around the world, you’ll join an international and highly dynamic work environment, at their state-of-the-art site in Holbæk (with the possibility of working remotely some of the time). Currently, we are a small, but dedicated team of 3 highly experienced International QA Directors, and we look forward to welcome you, to our team. We work closely together with our colleagues in Regulatory Affairs, Supply Chain, QA and Clinical, as well as with our external Partners and Contract Manufacturers. We are driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, in a fun and flexible working environment and friendly atmosphere.
about the job
As our new International QA Director, you will have an independent role with a wide range of operational tasks and responsibilities in a challenging position that offers broad responsibility, significant influence and high independence. With your thorough understanding of customer needs, and your strong understanding of quality processes, you want to challenge the status quo when making decisions on quality management. As a member of the GMP steering committee and quality management, you want to set a clear direction that inspires for continuous development. The position will be a part of a team bringing a new drug to the market from early clinical trials to a fully commercialized product.
Your primary responsibility will be to secure efficient handling of all quality matters as well as auditing CMOs related to outsourced manufacturing activities. You will be challenging current setups and optimizing established processes. Effective communication is key, as you will be responsible for creating strong relationships and handling continuous dialogues, presenting complex ideas and explaining them clearly to both internal and external stakeholders at all levels. As International QA Director you will ensure that the company’s external and outsourced activities comply with the company’s own requirements, applicable rules for good manufacturing and distribution practice (GMP and GDP) and other applicable rules.
The International QA Director reports to the VP for Quality and Regulatory Affairs.
KEY RESPONSIBILITIES
You will make sure that the quality is current and maintained with all CMOs, vendors, subsidiaries and partners with the primary focus on aseptic and sterile contract manufacture. You will conduct surveillance and audits of the contract manufactures and packaging sites; ensuring compliance with the agreed terms specified in the quality agreement (technical agreement), cGMP and GDP. You will ensure that all existing legislation is implemented in all relevant external collaborations. By participating in technology transfers between external stakeholders to supervising development projects and auditing both CMOs, distributors and vendors, you are guaranteed a developing job, both professionally and personally, within International Quality.
about you
You have a MSc level education (or higher) in Pharmacy or a similar field and +10 year of experience as a QA Manager/Director or Sr. Specialist (this combined with production experience would be an advantage). Preferably you also have a few years of experience with international project management. You want a role that offers flexibility, while providing you with strong ownership of your areas of responsibility.
In addition, we expect you to:
- Have a strong understanding of quality processes
- Be highly experienced with GMP/GDP regulations from the pharma industry within aseptic and sterile manufacturing
- Have experience working with CMOs in general, external audits and Quality agreements (technical agreements)
- Experience with analytical methods and Pharmacopoeias is an advantage.
- Be customer focused, and can establish a good collaboration with internal and external stakeholders
- Have excellent English communication skills: Negotiation level in both verbal and writing
- Have strong interpersonal skills – robust with natural authority, easy going
- Set clear direction - inspires for continuous improvement
- Have a likeable/positive personality
- Be a decision maker who challenges status quo
- Understand business and customer needs; a ‘doer’ – getting things done, also when the pressure is high
- Communicates effectively at all levels and presents complex and/or new ideas with clarity and simplicity
- Analytical and systematic
we offer
An independent and influential function in global settings, with a broad range of tasks and responsibilities. An opportunity to join a small and dedicated team with an open and friendly atmosphere. A large number of talented and dedicated colleagues across functional disciplines. Inspiring and flexible working environment. An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth. An attractive and competitive compensation package.
Travelling
20-25 days a year
Contact
Black Swan Exist, Daniel Hede Olsen, is responsible for the recruitment process on behalf of Pharmacosmos A/S. You can get more information about the job by calling Daniel +45 3160 9381. You can also click on the blue button in the top right and send an e-mail to Daniel.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 25.9.2019, 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
- Holbæk
- Mandag den 15. maj 2023
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