Curia is looking for a Quality Assurance Manager to oversee conditions and activities in a manufacturing facility to ensure continual compliance with cGMP for Biologics Drug Substance manufacture.
Requirements
- Biologics GMP experience
- Aseptic Processing experience, establishment of contamination controls
- Ability to gown and work daily in an aseptic manufacturing environment
- Proficient in Microsoft Excel, Word, PowerPoint
- Knowledge of basic quality tools (i.e. pareto charts, histograms, cause-and-effect, root cause analysis)
- Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations
- Ability to calculate formulas and amounts such as: concentration, percentage, area, volume, and proportion
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
Other
- Demonstrated ability to mentor and coach with the ability to motivate teams to reach a common goal
- Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures
- 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 environment with at least 2 years in a leadership role OR Master’s Degree in Microbiology, Biochemistry, Biotechnology or related field and a minimum of 3 years of relevant work experience in an FDA-regulated pharmaceutical environment with at least 2 years in a leadership role
- This position does have supervisory responsibilities.
- 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.
