The Director of Quality Control is the leader of Quality Control/ Stability laboratory and the Method Transfer/ Validation function. They are the head of Quality Control for the testing of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial products.
Maintain the Quality Control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics
Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
Ensure continuous improvement and effectiveness of the quality control labs
Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas
Interview, hire, train, develop and manage employees
Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
Investigate and document out-of-specification results and deviations during product testing
Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing
Minimum Qualifications:
Required:
Master’s Degree in Chemistry or Chemical Engineering with a minimum of 5 years’ work experience in GMP manufacturing or
Bachelor’s Degree in Chemistry or Chemical Engineering with a minimum of 8 years’ work experience in GMP manufacturing
At least 3 years management experience
Knowledge of cGMP and FDA regulations
Exhibit detail oriented documentation skills
Excellent written and oral communication skills
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one’s time
Communicate effectively and ability to function well in a team environment
Preferred:
PhD in Chemistry
Experience with Peptides and Oligomer manufacturing processes
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