Quality Assurance Manager

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DescriptionTFS is a Global CRO with headquarters in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.TFS HealthScience is currently looking for a Quality Assurance Manager to a well-known big pharmaceutical company as part of a rebuild of their Quality team. We are actively interviewing so don’t hesitate to send your application now!Job ResponsibilitiesAs a member of the Quality Team you will be working close together with the QP to maintain and improve the local Pharmaceutical Quality System. You will together with the QP be responsible for the oversight and performance of quality activities at the client and also work as his/her backup.As a member of the QA Team you will be a single contributor who works across networks with colleagues of other responsibilities as well as with peers in other countries. You will be named on our wholesaler, distribution and narcotic license. You will have the QMS-oversight and are responsible to ensure compliance with global and local regulations as well as the clients internal regulations.You will have the authority to be the main contact and represent the client in all quality and GDP/GMP related interactions with the Medical Products Agency (Läkemedelsverket). You will be the first contact person at the client in, and responsible for, general product quality related issues.You will work with a broad variety of topics from clinical to launch phase as well as mature products. Important responsibilities include, but are not limited to, handling product releases, complaints and CAPAs. Also active contribution or leadership in relation to globally initiated or cross-country driven projects will be an important part of your role.You will also be on boarded into regulatory activities. You will then have a permanent part of your time assigned to the QP/RP activities and are flexible assigning the remainder of the time according to needs in either of the areas.Who You AreRequirementsIt is expected that you are able and willing to dig into the details yet keep an eye on the overall goal. You are result- and customer oriented and have excellent interpersonal skills. You feel comfortable working with deadlines in an often changing environment and like to solve issues in a pragmatic and proactive way. Depending on the topic this is often in collaboration with colleagues from the company or peers from across the company.An open eye for the needs of the internal and external stakeholders and the ability to adjust to these needs while ensuring compliance is essential. You are looking for lean processes and do that through always looking for and sharing best practices with peers in other countries as well as looking for external inspiration.Your key relationships are both colleagues within the company, especially Logistics and other quality functions and with our external stakeholders, such as Läkemedelsverket and our 3PL.Important qualifications to be successful in this role:

• Must have: Pharmaceutical education or similar with at least 4 years of academic studies and fulfilling the very detailed requirements stated by the Medical Products Agency (=Läkemedelsverket) in the regulation LVFS 2004:7 "Krav på sakkunnig" 7
• as well as "allmänna råd till" 7
• .
• Solid understanding of the pharmaceutical industry
• Minimum 5 years’ experience working in QA in a GMP/GDP environment
• Curiosity to learn new areas to take over eg. regulatory tasks over time
• Excellent communication skills (oral and written) in both Swedish and English language.
• Solid knowledge of relevant GMP/GDP regulations both in the EU and in Sweden and ability to find solutions that are compliant with regulations while being fit for purpose
• Strong collaboration and influencing skills, able to find a pragmatic solution balancing stakeholder and regulation requirements
• Strategic thinker that is able to connect to the bigger picture
• Able to understand when alignment with other stakeholders or peers is required to ensure big picture understanding.
• Collaboration champion and believe in the power of networks and working cross-country to achieve goals in a lean and efficient way.
• Comfortable taking decisions in ambiguity
• Strong organization skills with ability to organize, prioritize, manage multiple tasks while ensuring the relevant information is in place

Who The Client AreWe offer a role with challenging and varied tasks and with great opportunities to actively contribute to the company’s continued development and are looking for an individual that wants to actively contribute to our success.