Supervisor, Quality Program Management

Curia • Albuquerque, NM

6d • Onsite

About The Position

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor is responsible for fostering strong client quality relationships and ensuring the timely review and disposition of executed batch records (clinical, commercial, and media fills). This role works closely with cross-functional teams to monitor and support the stages of the batch disposition process, including manufacturing and quality reviews, to ensure deliverables are completed on schedule to meet supply commitments. Key responsibilities include supporting the establishment, tracking, and improvement of batch record review and disposition cycle times. The role also involves coordinating shipments with the warehouse, participating in critical DEV review meetings to provide quality input, and contributing to the preparation of weekly and monthly metrics for senior leadership. Additionally, the supervisor will assist with identifying and implementing process improvements and support other QA areas as assigned by QA management.

Requirements

• Bachelor’s degree in in Science, Chemistry, Biology or related field of study
• Minimum of three (3) years in Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) year in a leadership role
• Ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations
• Strong written and verbal communication skills
• Effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages
• Strong grasp of algebraic and geometric principles
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Minimum of three (3) years in an aseptic/sterile product facility, preferred
• Knowledge in current regulations (21CFR, Annex 1 etc), preferred

Responsibilities

• Supervise and provide guidance to the QA batch record review and product disposition team
• Support client Quality relationships through effective communication and timely deliverables
• Review and assist in the disposition of executed Batch Records (Clinical, Commercial, & Media Fills) and collaborate with cross-functional teams to address review comments
• Maintain the record review planner to track and monitor the stages of the batch disposition process, including manufacturing and quality reviews and quality disposition processes
• Support efforts to monitor and improve batch record review and disposition cycle times
• Assist in tracking metrics for the review and disposition process and provide input for monthly performance analysis
• Oversee Disposition timelines and support client calls related to Disposition schedules and delays
• Ensure timely responses to client comments on Batch Records
• Coordinate with QC labs, external testing, and the deviations team to ensure all deliverables are completed on time to meet supply commitments
• Coordinate shipments with the Warehouse (including Q Ships & Release Shipments)
• Participate in critical DEV review meetings and provide quality input as needed
• Contribute to the preparation and presentation of weekly and monthly metrics for leadership
• Assist in developing batch record review training materials for Quality and Production teams
• Review and provide input on SOPs related to the functional area
• Support internal, client, and regulatory audits for batch record reviews
• Identify process improvements and assist in their implementation
• Provide 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

Benefits

• 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 with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Manager