Curia
Manager, Quality Program Management
Curia, Albuquerque, New Mexico, United States, 87101
Location:
Albuquerque, New MexicoManager, Quality Program Management
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.The Quality Program Management Manager will lead and manage our QA batch record review and product disposition team. The manager is responsible for maintaining strong client quality relationships and ensuring the timely review and disposition of executed batch records (clinical, commercial, and media fills). This role collaborates with cross-functional teams to track and measure the stages of the batch disposition process, encompassing both manufacturing and quality reviews, and to ensure all deliverables are completed on time to meet supply commitments.Key Responsibilities:Lead and manage QA batch record review and product disposition team.Manage client Quality relationships.Review and Disposition executed Batch records (Clinical, Commercial & Media fills) and work with cross functional teams to address review comments.Maintain record review planner to track and measure the stages of the batch disposition process.Establish, monitor and improve batch record review cycle times and batch disposition cycle times.Define metrics for the review and disposition process and measure on a monthly basis to drive and improve performance.Lead and manage Disposition timelines and client calls relating to Disposition schedule and delays.Ensure that responses to client comments on Batch Records are addressed in a timely manner.Coordinate with QC labs, external testing, deviations team to ensure all deliverables are completed on time to meet the supply commitments.Manage Shipments with Warehouse (Both Q Ships & Release Shipments).Participate in critical DEV review meetings and provide quality input.Lead weekly and monthly metrics and present to SLT.Develop batch record review training for Quality and Production groups.Revise, review and approve SOP’s related to the functional area.Support Internal, Client & Regulatory audits for batch record reviews.Identify process improvements and implement.Support in other QA areas as assigned by QA Management.Read/interpret SOPs to ensure compliance.Maintain up to date trainings.Other duties as assigned.Education and Experience:Bachelor’s degree in Science, Chemistry, Biology or related field of study.Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management.Minimum of two (2) years in a leadership role.Minimum of five (5) years in an aseptic/sterile product facility, preferred.Knowledge in current regulations (21CFR, Annex 1 etc), preferred.Supervisory Responsibilities:This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.Other Qualifications:Must pass a background check.Must pass a drug screen.May be required to pass Occupational Health Screening.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work Environment:The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All interested applicants must apply online. Curia is an Equal Opportunity Employer.
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Albuquerque, New MexicoManager, Quality Program Management
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.The Quality Program Management Manager will lead and manage our QA batch record review and product disposition team. The manager is responsible for maintaining strong client quality relationships and ensuring the timely review and disposition of executed batch records (clinical, commercial, and media fills). This role collaborates with cross-functional teams to track and measure the stages of the batch disposition process, encompassing both manufacturing and quality reviews, and to ensure all deliverables are completed on time to meet supply commitments.Key Responsibilities:Lead and manage QA batch record review and product disposition team.Manage client Quality relationships.Review and Disposition executed Batch records (Clinical, Commercial & Media fills) and work with cross functional teams to address review comments.Maintain record review planner to track and measure the stages of the batch disposition process.Establish, monitor and improve batch record review cycle times and batch disposition cycle times.Define metrics for the review and disposition process and measure on a monthly basis to drive and improve performance.Lead and manage Disposition timelines and client calls relating to Disposition schedule and delays.Ensure that responses to client comments on Batch Records are addressed in a timely manner.Coordinate with QC labs, external testing, deviations team to ensure all deliverables are completed on time to meet the supply commitments.Manage Shipments with Warehouse (Both Q Ships & Release Shipments).Participate in critical DEV review meetings and provide quality input.Lead weekly and monthly metrics and present to SLT.Develop batch record review training for Quality and Production groups.Revise, review and approve SOP’s related to the functional area.Support Internal, Client & Regulatory audits for batch record reviews.Identify process improvements and implement.Support in other QA areas as assigned by QA Management.Read/interpret SOPs to ensure compliance.Maintain up to date trainings.Other duties as assigned.Education and Experience:Bachelor’s degree in Science, Chemistry, Biology or related field of study.Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management.Minimum of two (2) years in a leadership role.Minimum of five (5) years in an aseptic/sterile product facility, preferred.Knowledge in current regulations (21CFR, Annex 1 etc), preferred.Supervisory Responsibilities:This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.Other Qualifications:Must pass a background check.Must pass a drug screen.May be required to pass Occupational Health Screening.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work Environment:The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All interested applicants must apply online. Curia is an Equal Opportunity Employer.
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