Manager, Quality Compliance

Manager, Quality Compliance 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!

Summary:

The Manager of Quality Compliance plays a critical leadership role within the Curia Albuquerque team, overseeing key elements of the Quality System to ensure sustained regulatory compliance and continuous improvement. This role is responsible for leading internal and external audits, managing Annual Product Quality Reviews (APQRs), and supporting customer and regulatory interactions. The Manager ensures alignment with Curia Global Standards and applicable regulatory guidelines, including ICH Q10, FDA 21 CFR Parts 210/211, EMA, and other international health authorities.

The position leads the inspection readiness program, facilitates gap assessments, and drives the execution of remediation plans to address audit findings. This individual provides strategic guidance to site teams on Quality System improvements, supports Quality Improvement Plans (QIPs), and utilizes metrics to monitor trends and identify areas requiring action. The role requires strong cross-functional collaboration and the ability to lead compliance initiatives across departments to meet quality objectives and regulatory expectations.

Essential Duties and Responsibilities:

+  Lead and manage the Annual Product Quality Review (APQR) process to ensure timely and accurate completion of customer reports by leveraging internal teams and corporate (GSS) resources.

+  Oversee and drive continuous improvement initiatives across the site to ensure regulatory compliance.

+  Direct internal and external audit activities, including planning, hosting, and response development, to ensure alignment with regulatory expectations.

+  Maintain and improve the site's inspection readiness program to ensure the facility is always prepared for customer and regulatory inspections.

+  Perform and lead gap assessments related to compliance issues; develop and execute remediation plans to address audit and inspection findings.

+   Lead and manage the supplier qualification program.

+  Guide cross-functional teams in the resolution of quality issues and lead implementation of Quality Compliance enhancements.

+  Monitor Quality performance using key compliance metrics, identify trends, and escalate issues requiring immediate corrective action.

+  Support Quality Improvement Plans (QIPs) tied to site-wide quality and compliance initiatives.

+  Provide subject matter expertise and interpret regulatory requirements, including FDA , ICH, EMA, and other global standards.

+  Ensure timely completion and execution of commitments related to customer audit and regulatory inspection responses.

+  Provide compliance guidance and mentorship to internal stakeholders to ensure adherence to SOPs, regulatory standards, and company policies.

+  Stay current with evolving GMP regulations and industry best practices to proactively identify compliance risks and improvement opportunities.

+  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 field of study

+  Minimum of five (5) years  relevant experience in  quality assurance and/or compliance/auditing experience

+  Minimum of two (2) years in a team leadership role of professional level individual contributors

+  Minimum of five (5) years is in the pharmaceutical industry, aseptic/sterile product facility or related industry

Supervisory Responsibilities:

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language

Skills:

The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling…