Manager, Quality Assurance

MANAGER, QUALITY ASSURANCE in Hopkinton, MA

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.

The Quality Assurance Manager is responsible for oversight of the conditions and activities in the manufacturing facility to ensure continual compliance with cGMP. This position requires expertise in all aspects of Biologics Drug Substance manufacture, Contamination Controls, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing facility and will report metrics to site management on a regular basis.

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! 

Supervisory responsibilities

This position does have supervisory responsibilities.

Responsibilities

• Lead Quality Assurance team and enable the Site Quality Head in establishing a Quality System for Biologics Drug Substance clinical and commercial manufacturing 
• Establish and maintain a risk-based and scientific-based quality system to meet business needs
• Through a quality system approach, ensure all GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
• Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials 
• Oversee and assist with the site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications
• Play a key role in the review of customer Quality Agreements and act as a key interface with the customers for Quality issues
• Make recommendations and drive implementation including Quality oversight for   facilities, equipment, personnel, procedures, and systems 
• Ensure that the data integrity principles are understood and implemented consistently throughout the site
• Play a key role in driving Quality performance through KPI’s, develop and drive action plans for key indicators outside of targets
• Lead process improvement program including collaboration with Operations, Quality, and/ or Training Leadership to make recommendations for enhancements to quality processes, teaching/coaching, and implementation of procedures
• Ensure a robust manufacturing quality oversight program is established and followed for GMP runs, including gowning into clean-rooms where necessary
• Support the site Quality Head in the implementation of commercial Quality System for Biologics DS manufacture 
• Quality oversight for the implementation of electronic systems for Quality workflows 
• Responsible for Quality disposition of GMP batches
• Coordinate corrective action training based on both immediate and long-term feedback gathered from observations and evaluations
• Assist Site Quality Head, during inspections by regulatory authorities, including implementing inspection-readiness programs and ensuring that proper CAPAs are prepared and completed on time
• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong, site-wide quality culture while achieving the site business goals. This includes also leading and supporting site-wide cGMP training activities
• Communicate effectively with internal and external customers making sure that the Curia values and business goals are consistently achieved
• Ensure daily inspections are being carried out

Qualifications 

Education, experience, certification and licensures

Required

• Bachelor’s Degree in Microbiology, Biochemistry, Biotechnology or related field and a minimum of 5 years of relevant work experience in an FDA-regulated pharmaceutical env