Director, Quality Assurance

A brief overview

The Director of Quality Assurance, in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). The person in this role will oversee Quality Assurance (QA) personnel, will ensure the review/approval of draft, and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and validation records. This position will also manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. The Director of Quality Assurance is responsible for coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the site and business.

What you will do

• 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 continuos improvement and effectivenss of the quality managemnet system.
• Oversee work of direct reports; distribute workload, and cross train staff on different quality areas. Interview, hire, train, develop and manage employees.
• All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements.

Qualifications

• 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)