Quality Program Manager II jobs in United States
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Curia ยท 11 hours ago

Quality Program Manager II

Curia is a global contract development and manufacturing organization focused on providing life-saving treatments. The Quality Program Manager II is responsible for managing quality-related activities, ensuring compliance with regulations, and driving continuous improvement initiatives within the quality management team.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote
Hiring Manager
Hang Nguyen
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Responsibilities

Acts as the primary quality assurance contact for CURIA-Albuquerque clients
Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines
Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products
Interfaces with the other CURIA-Albuquerque departments to communicate and maintain a partnership necessary for on-going operations and ensure the highest quality standards and regulatory compliance
Supports CURIA-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits
Presents project updates to internal and external stakeholders
Provides all additional quality assurance support and functions as specified by the Director of Quality Operation
Will act as subject matter expert for all quality issues related to batch release
Will help drive continuous quality improvement initiatives
Will provide quality training related to batch review, sitewide
Read/interpret SOPs to ensure compliance
Maintain up to date trainings
Other duties as assigned

Qualification

GMP experienceQuality assuranceRegulatory complianceBatch record reviewCAPA managementQuality trainingBusiness acumenCommunication skillsAttention to detailProblem-solvingTeam collaborationPresentation skillsTechnical writingMentoring

Required

Bachelor's degree in Science or related study
Minimum of three (3) years of GMP experience in an FDA regulated pharmaceutical environment
Acts as the primary quality assurance contact for CURIA-Albuquerque clients
Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines
Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products
Interfaces with the other CURIA-Albuquerque departments to communicate and maintain a partnership necessary for on-going operations and ensure the highest quality standards and regulatory compliance
Supports CURIA-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits
Presents project updates to internal and external stakeholders
Provides all additional quality assurance support and functions as specified by the Director of Quality Operation
Will act as subject matter expert for all quality issues related to batch release
Will help drive continuous quality improvement initiatives
Will provide quality training related to batch review, sitewide
Read/interpret SOPs to ensure compliance
Maintain up to date trainings
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations
Possess strong written and verbal communication skills, along with effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages
Possess a 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
Possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions
Essential skills encompass 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, sitewide
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
Ability to work promptly and under pressure to meet customer and business deadlines associated with batch record lot release

Preferred

Minimum of two (2) years of experience in a Quality position, preferred

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
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase