CEE Quality Manager, Responsible Person

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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.

Making animals’ lives better makes life better – join our team today!

Position Title:

Quality Manager CEE, Responsible Person

Supervisor Title:

Director, Quality EMEA

Position Type:

Full Time

Job Function:

CEE Leader, Responsible Person

Location:

Warsaw, Poland

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.

Additionally, this position holder may act as the Responsible Person as described in:

• Polish legislation - Pharmaceutical Act of 6 Sept 2001 (OJ. 2001 No 126 pos. 1381),
• COMMISSION IMPLEMENTING REGULATION (EU) 2021/1248 of July 29, 2021 on good distribution practice measures for veterinary medicinal products pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council,
• Local and global company policies.

Functions, Duties, Tasks:

• Lead the affiliate management to ensure that all operations of the affiliate comply with applicable GxP, other applicable company quality standards and local regulations.
• Effectively partner with affiliate leaders to ensure proactive identification and resolution of issues.
• Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
• Accountable for product quality related matters, escalate any local product quality related issue to regional quality leadership and affiliate management and lead / collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.).
• Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, procedure reviewer and approver and maintenance of the Quality Plan.
• 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).
• Ensure that distribution, product release and warehousing are compliant with Elanco standards and external regulatory requirements (i.e. products returned/reintegration, products recall).
• Raise Notifications to Management if, and when required.
• Halt, hold or quarantine product status if, and when required.
• Monitor, trend, interpret & report on Quality metrics & lead continuous improvement activities, in areas including, but not limited to, quality events such as deviations and customer complaints.
• Develop local talent to sustain competitiveness; this includes coaching employees; developing and implementing impactful training plans; managing & evaluating performance against expectations / scorecard.
• Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
• Perform any other duties or serve in such other capacity as may be determined by Company management.
• Accountable for the completion & accuracy of GMP+ quality tasks, including but not limited to HACC team member, maintenance of quality manual, RASCI matrix, annual self-inspection and annual mock recall.
• Management/supervision of CEE Quality Team.

Acting as 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.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status