Quality Program Manager II
Curia
Summary
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.
Job description
Summary
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.
Essential Duties and 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
Education and Experience
- 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
Supervisory Responsibilities
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Other Skills and Abilities
- 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
Other Qualifications
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain media qualification
- May be required to wear a respirator
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
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain media qualification
- May be required to wear a respirator
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.