Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
Manage, support and participate in regulatory inspections, manage customer Quality audits, serving as the point of contact and represent QA on project teams
Manage Quality Data Analytics and provide KPI data to QA
Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements
Manage Quality Management Review and APR
Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review
Establish head count needs for the QA group and recruit, train and manage personnel to meet the business needs of the company
Perform cGMP internal audits and cGMP surveillance across the BAM sites
Resolve day to day issues within functional departments and provide compliance assistance as needed, ensuring continuous improvement and effectiveness of the quality management system
Oversee work of direct reports; distribute workload, and cross train staff on different quality areas
Interview, hire, train, develop and manage employees.

Bachelor's Degree in Science related field or Master's Degree or Ph.D. in Science related field (Preferred)
10+ years work experience in a Quality field for GMP company
5+ years management experience (Preferred)
Knowledge of GMP, ISO, FDA, EU and international regulations
Ability to direct, mentor and motivate others
Excellent written and oral communication skills including data analytics
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to manage critical projects to deadlines as part of an interdisciplinary team
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
Communicate effectively and ability to function well in a team environment
Presentation skills, technical writing and editing skills
Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business
Certifications: QPA, CQA, CQE (Preferred)

Director, Quality Assurance

Key skills