Manager, Quality Program Management in Albuquerque, NM
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 include establishing, monitoring, and improving batch record review and disposition cycle times. The role also encompasses managing shipments with the warehouse, participating in critical DEV review meetings to provide quality input, and presenting weekly and monthly metrics to the senior leadership team. Additionally, the manager will identify and implement process improvements and support other QA areas as assigned by QA management.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
We proudly offer:
Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401k program Learning platform And more!
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. This includes both manufacturing and quality reviews and quality 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 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
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
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. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.
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.
The essential physical demands will vary for each Curia position.
All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing
and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment:
The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.
The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.