Quality Program Manager II

Curia • Albuquerque, NM

6h

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 Manager II is a key member of the quality management team, responsible for ensuring the effective execution of quality programs within the framework of cGMP regulations. This mid-level role interfaces with internal and external stakeholders, including CURIA-Albuquerque customers, to manage quality-related activities, resolve issues, and facilitate batch release processes in accordance with customer and regulatory requirements.
The Quality Program Manager II collaborates closely with the Director of Quality Operations to support continuous improvement efforts, identify potential risks, and drive initiatives aimed at enhancing product quality and operational performance. This role is also tasked with managing customer quality expectations, working with cross-functional teams to resolve quality issues, and ensuring the timely resolution of deviations and CAPAs. The Quality Program Manager II will contribute to developing and refining processes to meet the evolving needs of the business while ensuring compliance with both internal and external quality standards.

Requirements

• Bachelor’s degree in Science or related study
• Minimum of three (3) years of GMP experience in an FDA regulated pharmaceutical environment
• Minimum of two (2) years of experience in a Quality position, preferred
• The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should 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. Candidates must 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.
• The ideal candidate will 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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• May be required to obtain and maintain media qualification
• May be required to wear a respirator

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

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: Mid Level