Quality Manager

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 Description:

As the central quality contact for the Elanco Marketing Affiliate organization, the QUALITY MANAGER advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in Korea, to the appropriate affiliate management, Director of Quality ANZ and Korea, Regional and Corporate management when needed.

Functions, Duties, Tasks:

CORE JOB TASKS

• Be responsible for product quality related matters, escalate any local product quality related issue to the Director of Quality ANZ and Korea and the affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
• Implement and monitor product quality systems and Quality Manual in the Marketing affiliate.
• Assist affiliate management, Director of Quality ANZ and Korea, in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards and local regulations.
• Manage vendors through risk assessments, quality assessments and Quality Agreements as per internal requirements.
• Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA) and use of a Quality Plan.
• Halt, hold or quarantine product status as required.

SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY

• Quality Management
• Ensure affiliate compliance with Good Manufacturing Practices (cGMP), Good Warehousing practices for finished products and all relevant local regulations.
• Ensure Quality updates and Annual management review are conducted at Affiliate Lead Teams.
• Ensure Notification to Management within one day of identification.

• Quality Systems

Batch Release

• Ensure products received comply with the market authorization, by approving/rejecting batches.
• Where QC testing of Finished Products is a local regulatory requirement, ensure good sampling and distribution practices

Change and Event Management

• Create, execute and close change controls that may affect the quality attributes of the product. Assist owners and management with the change control system.
• Create and resolve deviations (events) from normal procedures that could potentially impact safety, identity, strength and quality of the product. Ensure deviation completion is within requirements and corrective and preventative actions are completed by the target date.
• Maintain local procedures where there are stricter local regulations.
• Create or review relevant quality related documents.
• Ensure record retention of documentation as per appropriate record retention period
• Review testing methods used in dossier submissions to confirm compliance with local Pharmacopeia and capability of local laboratories.

Personnel Qualifications

• As Wholesaler Management Pharmacist, maintain pharmacist license by attending applicable local training by appropriate regulatory body.
• Maintain a job description and career profile that describes the quality duties and review it every two years.
• Review and approve GMP training material generated by the local affiliate.
• Perform GMP training or equivalent (as required).
• Ensures training records by the local affiliate are documented

Quality Plan

• Create and track Quality plan actions associated with compliance gaps to local regulations or internal standard requirements, as well continuous improvement initiatives.
• Adhere to and meet Quality plan actions target due dates.

Auditing and Inspections

• Conduct self-assessments of quality systems at least annually, to maintain a state of inspection readiness at the affiliate.

• Facilitate and co-ordinate Regulatory Agency inspections, EGQCA audits of the affiliate and vendors as per the internal audit plan. Support the affiliate with the audit readiness plan. Take daily notes and report on the daily audit activities as per internal requirements.
• Prepare written responses to internal audits by consulting with the Director of Quality ANZ and Korea.
• Prepare written responses to regulatory agency inspections by consulting with Director of Quality ANZ and Korea, APAC Affiliate Senior Quality Director, Global Senior Quality Director and Director of Auditing and Compliance. Ensure timely responses and execution of actions by target due dates.
• Review and consult on all new business deals that require quality operations with the Director of Quality ANZ and Korea.
• Manage vendors through risk assessments, quality assessments and Quality Agreements as per internal requirements.

Regulatory Interactions with Government Agencies

• Document in agreement with the Director of Quality ANZ and Korea, any potential regulatory reportable event because of a product defect. Ensure adherence to reporting timelines.
• Provide information required for NTMs such as but not limited to site notification of a regulatory inspection (announced and unannounced), requests for regulatory responses to product quality related matters, agency requests for non-routine samples (drug product) and communications of potential restriction on product supply to management and regulatory agencies
• Participate in communications with the regulatory agencies on a product quality related matter.

Adverse Events and Product Complaints

• Ensure a process is in place to report adverse events and product complaints as per Elanco Quality standard and local regulations
• Ensure a process is in place to coordinate timely complaint sample returns in the event a product complaint investigation is required by the investigation site
• Ensure compliance with any local requirements related to product complaints in the affiliate
• Ensure compliance with local quality agreements
• Ensure timely response to customers if necessary
• Represent product complaints in Marketing Affiliate inspections as needed
• Escalate serious quality issues e.g. counterfeit, tampering, potential recalls to the APAC Affiliate Senior Quality Director.
• Liaise with Global Product Security on all counterfeit or tampered products complaint reports

Recalls

• Ensure immediate reporting of a significant quality and/or safety issue is conducted in conjunction with the Director of Quality ANZ and Korea
•  Execute the recall process when required, including recall recommendation, report, implementation and closure.
• Perform a recall simulation as per requirements.

Product Safety Assessment

• Determine which deviations or complaints affect customer or animal safety.
• Consult with Director of Quality ANZ and Korea on the need for a Product Safety assessment.

Computer Systems

• Assist in ensuring there is a process for managing GMP records from systems that are non-Electronic Signatory (ES) compliant

Materials Management

• Ensure a system is in place to manage the handling, accountability and traceability of inventory including free goods in accordance with local regulations and label storage conditions
• Request in consultation with the Director of Quality ANZ and Korea and APAC Affiliate Senior Quality Director, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product
• In conjunction with the Director of Quality ANZ and Korea, ensure a formal decision-making process exists for the disposal or redistribution of any returned, rejected, recalled and counterfeit product.
• Support the creation/update of Quality Agreements between Elanco sites
• Review product donations for compliance with applicable quality standards, local procedures and regulations

Distribution of Finished Products

• Ensure product shipped from one marketing affiliate to another meets the marketing authorization of receiving country.
• Consult on operating temperature and humidity (where applicable) ranges for storage areas
• Ensure inventory cycle counts are performed annually.
• Investigate significant confirmed cycle count discrepancies using the deviation process. Consult with the Director of Quality ANZ and Korea and gain approval on adjustments outside of accepted tolerances

Packaging and Labeling

• Ensure that appropriate labeling review and approval processes are in place
• Prepare appropriate labeling documentation for approval by Director of Quality ANZ and Korea or APAC Senior Director Quality as required by internal standards
• Provide quality oversight of local repackaging operations and notify Qualified Persons as required

• Environment Health and Safely
• Adhere to all safe working procedures in accordance with instructions
• Take reasonable care of self and others.

• Minimum Qualification (education, experience and/or training, required certifications):

• Skills: 

• PC Skills – Microsoft; Word, Excel, and Outlook
• Analytical/investigational skills
• Inventory management knowledge highly regarded.

• Attributes:

• Attention to detail
• Customer Focus
• Excellent interpersonal and communication (written and oral) skills
• Strong organization and planning skills
• Ability to prioritize and manage competing tasks and timelines
• Self-managed
• Cross functional collaboration and teamwork skills

• Experience:

  At least 2-5 years Quality experience in a GMP environment.

  Qualifications:

• Registered Pharmacist

• Additional Preferences:

  SAP Inventory system knowledge

  Pharmaceutical or Animal Health industry experience

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