Manager, Commercial Quality
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Quality
Would you like to join an award winning organization that is dedicated to saving lives?
At Xellia, we are looking for a Manager, Commercial Quality that is responsible for Developing, implementing and improving Quality Management Systems for the Xellia US commercial organization while providing key support for product release, good distribution practice (GDP) systems, product complaints and post approval marketing commitments. Responsible for ensuring compliance at Xellia Contract Manufacturer (CMO’s) located in US and ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identify opportunities for improvement. Make constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, DSCSA, FDA, PIC/S, WHO and other regulatory agencies.
Key Responsibilities
- Ensure North American Commercial and CMO oversight processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance, and establish systems that identify opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, and other regulatory agencies.
- Ensure Xellia’s Contract Manufacturing business is always inspection ready
- Review Xellia products for release to the US Commercial market, and US-CMO produced products for release to the US, EU and RoW, and assure that quality and compliance requirements are met prior to distribution. Support QP release for the EU.
- Review and approval of Manufacturing Process Control Records and executed Batch Production Control Records, Analytical data, ongoing stability studies and QMS notifications received from US CMO’s.
- Escalate third party compliance issues with sizeable impact to Xellia business and provide insights on how to close the gap to the Head of GPESQ and Quality Leadership Team (QLT).
- Interact with Customers to receive product complaints and respond to inquiries about product quality.
- Manage complaint investigations with various manufacturing sites, CMO sites and distribution service providers, driving timely evaluations and resolution.
- Interface with Xellia US Commercial customers for new private label product launches and ongoing communications post-launch
- Manage QMS training assignments for the US commercial site, assuring appropriate training assignments for GxP activities
- Collaborate with internal and outsourced GDP/Supply Chain team members to assure compliant and efficient distribution processes for US Commercial and US CMO produced products.
- Author and improve US Commercial and CMO related GMP/GDP procedures.
- Monitor and report key performance indicators in support of global and local goals and improvement initiatives.
Experience and Skills
- Bachelor Degree, science-related field preferred
- Minimum of 3 years’ experience in a Quality Management role, ideally in pharmacy, pharmaceuticals sciences, chemistry or related discipline
- Strong knowledge of GMP and GDP regulations and industry practices
- Analytical ability to critically evaluate and troubleshoot complex problems
- Robust conflict management and resolution skills
- Ability to communicate proficiently with all levels of the organization and its customers
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Demonstrated ability to effectively participate on multi-disciplinary teams
- Well-organized and meticulous professional, adept at providing an impeccable customer experience
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as the winner for the Best International Initiative for Business Culture. Recognized for our ability to encourage employees to succeed through projects that have a positive impact on the company's culture. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
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