Manager, Quality Control
Curia
Summary
The Manager, Quality Control is responsible for the oversight of the Quality Control function at the site. The Manager will oversee a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, continuous improvement, and reporting of results.
Job description
Essential Job Duties
- Manage and prioritize testing and operations of quality control team(s) involving samples as well as incoming, in-process and final products
- Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
- Supervise a team of analysts and technicians including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
- Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
- Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
- Organize workload and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
- Drive schedule adherence discipline and RFT performance with the supervisors and analysts
- Responsible for lab inspection readiness at all times
- Responsible for customer requests related to QC items
- Ensure the team compliance on initiating deviations, completing investigations and extensions to maintain regulatory compliance
- Ensure supervisors adhere to supervisor standard work for shift huddles
- Ensure there is a shift hand off process in place to transition QC operational activities
- Manage all investigations of OOS, deviations and change control management and CAPAs within the QC function
- Oversee and perform pharmaceutical analysis to support operations
- Mentor and train team members on applicable techniques and equipment
Knowledge, Skills and Abilities
- Ability to recognize what needs to be done, take action, and accomplish results
- Strong oral and written communication skills, including effective listening
- Demonstrated ability to effectively utilize team resources
- Expert in cGMP, USP, EP and FDA regulations
- Technical competence including the understanding of theory and interpretation of all lab techniques
- Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
- Strong organizational skills with the ability to multi-task
- Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
- Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
Requirements
- Bachelor’s degree in Chemistry, Analytical Chemistry or related field
- Minimum 5-8 years’ experience in a GMP or GLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation
- Minimum 2 years’ experience in professional management
- Experience in playing a key role in regulatory inspections
- Expert in cGMP, USP, EP and FDA regulations
- Proficient in HPLC and GC method development and method validation
- Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.