Senior Manager/Associate Director, CMC Quality Assurance

Job Summary: 

City Therapeutics is looking for a Sr. Manager/Associate Director, CMC Quality Assurance working under the Quality Head to support QMS and CMC activities ensuring compliance with applicable GMP regulations and regulatory requirements from R&D to commercial production activities. This candidate should have excellent written and oral communication skills and demonstrated abilities to work in a very dynamic environment. Please note this is an on-site opportunity.

Main Responsibilities: 

• QA operations to support and manage training programs/records for relevant employees in GxP environments especially CMC employees to support GMP activities. 
• QA reviews of manufacturing master batch records, executed batch records, product release and stability testing reports, method validation protocols/reports, pharmacology and toxicology study reports.
• Review specifications and specification justifications
• Work with CMC function in the evaluation and selection of CDMOs/CROs  
• Review quality agreements and support quality audits
• Review and approve change controls, deviations, investigations, CAPA, and Product Quality Complaints
• Review and update CMC sections of regulatory and quality documents  
• Interact with CMC, clinical operation, regulatory affairs or other functional areas and oversee the quality issues and identify actions.
• Support regulatory inspections
• Timely communications to management of compliance issues 

Qualifications: 

• Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry and related field and at least 5-8 years of direct experience in Quality Assurance in the biotechnology or pharmaceutical industry. 
• Experience in supporting early phase manufacturing using CDMOs/CROs
• Experience in document management and training management in QMS
• Experience in vendor qualifications and compliance audits is a plus
• Experience in oligonucleotide therapeutics is preferred.
• Good knowledge of US and EU GMP regulations
• Demonstrated effective communications/interactions with internal and external teams and individuals and problem-solving abilities
• Be able to travel domestically and internationally
• Demonstrated a great team player with professional integrity and work ethics
• Demonstrated ability to work effectively in a regulated and fast-paced environment 

City Therapeutics is accepting resumes/CVs from direct applicants only.  Recruitment Agency submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.