Overview

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Position Description: The purpose of this position is to provide administrative and technical direction to Manufacturing Quality team at the Fort Dodge site. Scope of Quality oversight includes all manufacturing operations: facility, equipment, computer system qualification, process/cleaning qualification, quality oversight of seed/cells, fermentation, downstream, blending and filling.

This position ensures that quality products are released to market through proper selection and training of staff, maintaining compliant status within the department and site.

Manager, Manufacturing Quality is responsible for identifying and implementing new quality initiatives, systems and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage.

Manager, Manufacturing Quality shares successful programs with other sites in Elanco network in order to build cross site processes.

This role oversees the quality oversight of facility and equipment lifecycle, computerized systems commissioning and qualification, quality oversight of process and cleaning validation and provides quality oversight of routine manufacturing operations and Quality on the Floor Process Team. The role has the responsibility of the product quality review program and the site self-inspection program in addition to supporting manufacturing investigations.

Quality Leadership

Routine manufacturing and sterility assurance

Process and cleaning validation

Facility and equipment lifecycle and CSQ

Product Quality Reviews

Site Self Inspections

Accountabilities

1) Leadership:

  • implements SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.
  • Identifies and escalates quality issues per the notification to management system.
  • Provides quality oversight to the manufacturing operations regarding compliant documentation approaches involving deviations, CAPA and complaints.
  • Responsible for providing technical guidance, training and oversight for the department and its members.
  • Prepares annual expense and capital budgets for area and monitors to stay within prescribed limits.
  • Present escalation topics impacting the area of oversight at Elanco Assessment Committee (EAC) meetings
  • Overall Department and individual Groups operate in an efficient manner, generating quality and timely data within an atmosphere which promotes staff development and growth.
  • New or upgraded procedures and policies are created and implemented in a timely manner.
  • Successful regulatory, third party and EGQCA audits/inspections
  • Ensure budgets are appropriately set to ensure company resources are used efficiently and appropriately.
  • Effective execution of the Quality management system to identify and respond to product, compliance and quality system risks.

2). Facility, Equipment and computerized systems Lifecycle

  • Quality oversight of facility, equipment and computerized system lifecycle.
  • Manages equipment and computerized systems master lists
  • Ensures compliance to applicable site procedures, EFPs and EGQS with respect to Facility, Equipment and computerized system qualification.

3). Quality oversight of process and cleaning validation

  • Strategically guides site in the development of process and cleaning validation programs applicable to the manufacture of vaccines
  • Manages media fill program including defining protocol requirements and final report approval
  • Ensures process and cleaning validation protocols and reports are in compliance with site SOPs, Elanco functional procedures and Elanco Quality standards applicable to vaccine manufacturing.
  • Ensures media fills are completed in compliance with site procedures and Elanco requirements

4). Routine Manufacturing and Sterility Assurance

  • Provides routine quality oversight of manufacturing operations through floor audits, line checks and routine walkthroughs.
  • Coordinates with manufacturing operations for reporting and resolution of manufacturing issues via the event reporting system.
  • Guides manufacturing personnel in compliant documentation approaches
  • Coordinates with manufacturing operations and microbiology department in identification of contamination risks and implementation of control strategies
  • Demonstrates improvement in RFT metrics
  • Reduction of errors in manufacturing documentation and batch records
  • Proactive in identifying and resolving contamination risks
  • Ensures inspection readiness of manufacturing areas

5). Product Quality Reviews (as applicable based on regulatory requirements)

  • Owner of product quality review program Trains department personnel in the Elanco functional procedure requirements as applicable to vaccine regulatory requirements
  • Develops annual product quality review schedule and reports metrics for completion against schedule
  • Ensures coordination between manufacturing, TSMS and QC in the development of the report
  • Approves product quality review reports
  • Proactively identifies weak products, processes and methods and identifies risk mitigation measures
  • Ensures compliance with Elanco requirements and applicable regulatory requirements for product quality review reports

6). Site Self Inspection Program

  • Owner of site self inspection program
  • Trains department, area leads, auditors on the site self inspection program
  • Identifies audit teams and develops annual site self inspection program
  • Approves reports and escalates critical findings to Site Quality Director and Site head per procedural requirements. Ensures compliant execution of the program per the Elanco standard.

7). Training management

  • Responsible for execution of training program for the department
  • Identifies required curricula for Quality hub team and performs annual reviews of training curricula
  • Collaborates with Hub operations department management in the development and review of employee curricula
  • Ensures compliance with Elanco quality system requirements for training at the site.
  • Completes own assigned training by target due dates
  • Identifies professional development opportunities for self and team.
  • Employee training curricula is compliant with requirements per the job descriptions
  • Ensures on time completion of training for the department
  • Training sessions are effective and consistent with adult learning methodologies
  • Routinely monitors assignments in learning system to assure training is always up to date. Training is completed on time and by due dates.
  • Proactively identifies training opportunities and leads classroom facilitated training for the department and the site.
  • Ensures training is completed prior to performing work

8). Manufacturing Investigations, Deviations and CAPA

  • Conducts training of employees on investigation reporting requirements.
  • Writes and/or reviews manufacturing investigations, as needed, to support the Quality and Compliance Team.
  • Writes or reviews department investigations to ensure compliance to procedural requirements, identification of Root cause and implementation of effective CAPA.
  • Champions prompt resolution of quality issues.
  • Supports deviation assessments to identify immediate actions, problem statement, appropriate escalation, etc.
  • On time completion of quality reports reflected in metrics; reports are clearly written and include the key elements required in investigations per the quality standard.
  • Identifies and escalates critical issues within 1 business day.
  • CAPAs are completed by target due dates.

​9). Projects

  • Actively identifies and leads project teams in alignment with site quality strategic direction
  • Champions idea generation and solution development/process improvement.
  • Provides data to support implementation and suggests new ways to apply existing knowledge.
  • Displays respect and appreciation for individual differences; values contributions of others

Required Capabilities:

Significant working and theoretical knowledge is required in order to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment and recommend improvements to improve compliance levels. Thorough and technical correct decision-making skills are required and in constant use in this position.

Experience in department oversight (organizational, budgeting, strategy) required

  • Well versed in all regulatory requirements, inclusive of cGMP/GLP and Elanco requirements.
  • Good knowledge of statistics, databases, and quality principles.
  • Ability to plan, schedule, organize, prioritize, and coordinate project activities.
  • Makes routine decisions with limited guidance from supervisor.
  • Recognizes and reacts to the significance of data/results.
  • Written and verbal communication with cross-functional groups.
  • Must be self-motivated and of high integrity
  • Ability to use technical knowledge to solve problems.
  • Ability to lead teams to achieve results.
  • Actively engaged in leadership and professional development of team members
  • Demonstrated high ethical and professional standards with all business contacts in order to maintain Elanco’s excellent reputation in the community.
  • Proficiency in relevant computer software programs associated with the area
  • Demonstrates proficiency in lean/5S/six sigma methodologies

Education/Experience:

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, Business Administration, Economics, Engineering or IS/IT.
  • Minimum of 10 years in a regulated pharmaceutical /vaccine manufacturing environment.
  • Must demonstrate ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally. Well versed in all regulatory requirements, inclusive of cGMP/GLP and BI requirements. Interacts with production, engineering, maintenance, planning.

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

Tagged as: MID TO SENIOR LEVEL

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