Quality Program Manager II
Role Overview
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.
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
Full Job Posting
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. 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.
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
- There may be other qualifications to add, ad hoc, such as the below:
- May be required to obtain and maintain media qualification
- May be required to wear a respirator
- Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
- 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.
Preferred Qualifications
- Minimum of two (2) years of experience in a Quality position, preferred
About Albany Molecular Research, Inc.
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