Quality Program Manager, NPI

Quality Program Manager, NPI in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

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.

We proudly offer

•    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!

The Quality Program Manager serves as the primary customer-facing Quality representative for assigned client programs at Curia's Albuquerque sterile manufacturing facility. Acting as the Quality counterpart to Project Management, this role provides strategic oversight and coordination of quality activities associated with New Product Introduction (NPI), technology transfer, process validation, commercialization, and lifecycle management of sterile pharmaceutical products.
The position serves as the primary liaison between customers and the Quality organization, ensuring customer expectations, regulatory requirements, quality agreements, and site quality systems are effectively integrated throughout the product lifecycle. The role works closely with Project Management, Manufacturing, Quality Control, Technical Services, Validation, Regulatory Affairs, Supply Chain, and Engineering to identify and mitigate quality and compliance risks while supporting successful execution of customer programs.
This position requires extensive experience in sterile pharmaceutical manufacturing, strong customer relationship management skills and the ability to influence cross-functional teams in a complex CDMO environment.

Essential Duties and Responsibilities:

Customer Quality Relationship Management
•    Serve as the primary Quality point of contact for assigned customer programs. 
•    Develop and maintain strong working relationships with Customer Quality, Technical Operations, Regulatory and Supply Chain representatives. 
•    Partner with Project Management in customer governance meetings, project reviews and escalation discussions to provide quality perspective, compliance guidance and risk assessments. 
•    Lead customer discussions involving quality systems, investigations, change controls, validation activities, product quality concerns and regulatory compliance matters. 
•    Ensure customer notification requirements are fulfilled in accordance with Quality Agreements and regulatory expectations. 
•    Support customer audits, site visits, due diligence assessments and quality-related business discussions.

New Product Introduction and Technology Transfer
•    Provide Quality oversight and strategic guidance for New Product Introduction (NPI), technology transfer, and commercialization activities. 
•    Participate in project planning activities to ensure appropriate quality support and risk management strategies are established. 
•    Coordinate quality deliverables required to support product transfers, process validation, analytical method transfers, cleaning validation and commercial launch activities. 
•    Assess quality and compliance risks associated with new products, manufacturing processes, facilities, equipment and analytical methods. 
•    Provide Quality input into transfer assessments, validation strategies and product control strategies. 
•    Ensure quality requirements are appropriately incorporated into project execution plans and timelines.

Quality Systems Coordination
•    Coordinate quality support activities impacting assigned customer programs, including: 
-    Deviations and investigations
-    Corrective and Preventive Actions (CAPAs)
-    Change controls
-    Risk assessments
-    Product impact assessments
-    Validation activities
-    Customer notifications
-    Product complaints
-    Annual Product Reviews / Product Quality Reviews
-    Regulatory commitments
•    Facilitate cross-functional discussions to ensure timely resolution of quality issues and customer concerns. 
•    Monitor quality system performance and communicate issues that may impact project milestones, product quality, regulatory compliance or customer commitments.

Compliance and Regulatory Support
•    Provide guidance on applicable FDA, EMA, Health Canada, ICH, and global cGMP requirements related to sterile pharmaceutical manufacturing. 
•    Support regulatory inspections, customer audits and remediation activities related to assigned programs. 
•    Evaluate quality and compliance risks and recommend appropriate mitigation strategies. 
•    Ensure activities supporting customer programs are conducted in accordance with internal procedures, regulatory requirements and approved Quality Agreements.

Cross Functional Program Support
•    Act as the Quality counterpart to PMO, ensuring quality activities remain aligned with overall program objectives and timelines. 
•    Collaborate with Manufacturing, QC, Validation, Technical Services, Regulatory Affairs, Supply Chain, Engineering and Project Management to support successful program execution. 
•    Escalate quality risks, compliance concerns and resource constraints that may impact project deliverables. 
•    Provide leadership and coordination during issue resolution activities involving quality-related customer concerns.

Continuous Improvement
•    Identify opportunities to improve NPI processes, technology transfer activities, customer-facing quality systems and cross-functional collaboration. 
•    Drive standardization and best practices for Quality support of customer programs. 
•    Support development and reporting of quality performance metrics associated with customer projects and new product introductions.
•    Read/interpret SOPs to ensure compliance
•    Maintain up to date trainings
•    Other duties as assigned

Education & Experience:     
Required
•    Bachelor’s degree in chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences or related scientific discipline.
•    Minimum 10-15 years of experience within the pharmaceutical, biotechnology or CDMO industry.
•    Minimum 8 years of Quality Assurance experience supporting sterile pharmaceutical manufacturing.
•    Demonstrated experience supporting New Product Introduction, technology transfer, validation and commercialization programs.
•    Experience serving as a customer-facing Quality representative within a GMP-regulated environment.
•    Strong knowledge of aseptic processing, sterile manufacturing, quality systems and global regulatory requirements.
•    Experience supporting sterile injectable products through clinical and commercial lifecycle stages. 
•    Working knowledge of aseptic processing, contamination control strategies, process validation, cleaning validation, environmental monitoring and microbiological controls. 
•    Experience supporting technology transfers, process performance qualification (PPQ), and New Product Introduction (NPI) programs. 
•    Familiarity with FDA, EMA, Health Canada, MHRA, and ICH expectations applicable to sterile drug product manufacturing.
Preferred
•    Advanced degree in a scientific or engineering discipline.
•    Prior experience in a sterile injectable CDMO environment.
•    Experience supporting FDA, EMA and Health Canada inspections.
•    PMP, ASQ, RAC or equivalent professional certification.

Supervisory Responsibilities:   
This position does not have direct personnel management responsibility; however, the incumbent is expected to provide leadership and coordination across cross-functional teams supporting customer programs, New Product Introduction (NPI), technology transfer, validation and commercial manufacturing activities. The position may provide mentoring, guidance and technical direction to Quality personnel and project team members.
 

Other Skills and Abilities:
•    Fosters a collaborative and positive work environment
•    Champions change
•    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 analyze complex technical, quality, operational and project-related information and apply risk-based decision-making principles. Ability to interpret quality metrics, statistical trending, validation data, process performance data and compliance information to identify risks and support business decisions.

Other Qualifications:
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
 

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.