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At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Position Description:
As the central quality contact for the Elanco Affiliate organization, the Quality Manager advises, decides, reports, consults and escalates quality matters relating to Elanco products distributed in CEE, to the appropriate affiliate management, Regional Quality Leader or Corporate management when needed. The Quality Manager provides independent quality oversight of GMP service providers and is responsible for ensuring that products meet the quality that customers expect. Lead the affiliate management to ensure that all operations of the affiliate comply with applicable GxP, other applicable company quality standards and local regulations. Work with the Responsible Person (if a different person) to ensure that Administrative verification is completed in accordance with the requirements set by the relevant Wholesale Distribution Authorization(s).
Responsible Person
- Ensure that a quality management system is implemented and maintained.
- Focus on the management of authorized activities and the accuracy and quality of records.
- Ensure that initial and continuous training programs are implemented and maintained.
- Coordinate and promptly perform any recall operations for medicinal products.
- Ensure that relevant customer complaints are dealt with effectively.
- Ensure that suppliers and customers are approved.
- Approve any subcontracted activities which may impact on GDP.
- Ensure that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures – CAPAs, are put in place.
- Keep appropriate records of delegated duties.
- Decide on the final disposition of returned, rejected, recalled or falsified products.
- Approve any returns to saleable stock.
- Ensure that any additional requirements imposed on certain products by national law are adhered to.
- Ensure the documentation of deviations and decide on appropriate CAPA to correct deviations and avoid their reoccurrence and monitoring of the effectiveness of those CAPA.
- Minimum Qualification (education, experience and/or training, required certifications):
Education:
- Master degree in pharmacy, or veterinary medicine;
- Relevant experience and meeting requirements according to Art. 84 of Pharmaceutical Act of 6 Sept 2001 (OJ. 2001 No 126 pos. 1381) to become accredited as a Responsible Person in Poland.
Experience:
- Demonstrated leadership / influencing skills in a cGxP environment; preferably within a Quality role.
- Ability to both lead and support; and a track record of business partnering with internal stakeholders.
- Effective communications (written/verbal), presentation and facilitation skills.
- Interpersonal savvy, with the capacity to build strong relationships at a senior level.
- Experienced in leading Regulatory Inspection audits and management of HA responses.
- Demonstrated analytical & investigational skills.
- Effective organizational and planning skills; managing near term priorities & strategic aspirations.
Additional Preferences:
- Fluent in Polish and English (written & verbal).
- Inventory management knowledge highly regarded.
