Manager, Quality Assurance

JOB SUMMARY:

The Manager, Quality Assurance is responsible for managing the oversight of quality operations at commercial service providers of API, device component and Drug Product, packaging and distribution to ensure that vendors are in compliance with applicable regulations (e.g. cGMP), and Quality Agreement (s), and relevant Standard Operating Procedures (SOP’s). 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls to ensure that performance and quality of commercial suppliers conform to established standards and regulatory agency requirements;
• Primary person for the oversight of master batch record review and approval, executed batch record review, assessment of deviations, change controls and analytical data;
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance;
• Works directly with commercial suppliers to ensure that operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA closures;
• Quality oversight responsibilities from validation to commercial scale up;
• Supports or leads external commercial quality audits, and supports ARS during CMO site inspections by regulatory agencies;
• Responsible for Annual Quality Review and supporting regulatory submission;
• Ability to work collaboratively and independently with commercial and development product manufacturing teams, business partners, CMOs and vendors;
• Manages and mentors Quality staff.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in science or related fields and 8+ years of relevant experience in a highly regulated manufacturing environment;
• In-depth knowledge of QA principles, concepts, industry practices, standards, computer systems validation and ICH Guidelines;
• Knowledge of performance measures and quality improvement statistical tools; 
• Demonstrated ability in exercising superior judgment and working independently with minimal supervision and/or guidance;
• Effectively adopt systematic approaches in order to maximize efficiencies and scalability;
• Ability to manage tasks with competing priorities or deadlines;
• Ability to understand / implement written and verbal instructions to all levels of the organization; including presenting in small groups;
• High level of professionalism and collaboration in team settings;

KNOWLEDGE, SKILLS, AND ABILITIES:

• Extensive experience working successfully with vendors, CMOs and leading a staff;
• Ability to travel up to 20%, depending on business needs;
• Fit with ARS culture and values.