The Manager, Commercial Quality Assurance is responsible for managing quality operations at Adamas commercial service providers of drug substance, drug product, packagers and distribution centers to ensure that Contract Service Providers are in compliance with applicable regulations, Quality Agreement(s), and Standard Operating Procedures (SOP’s). This role reports to the Senior Manager, Commercial Quality Assurance and is based in Emeryville, CA.
- 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;
- Responsible 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;
- Leads external commercial quality audits, and supports Adamas 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;
- Complies with corporate policies and procedures, as well as, US healthcare laws and regulations.
- Bachelor’s degree in science or related field and 5 to 7 years of relevant hands on experience in a highly regulated manufacturing environment;
- In-depth knowledge of QA principles, concepts, industry best practices, regulatory standards, and ICH Guidelines;
- Experience in of manufacturing, packaging, labelling, and distribution of oral solid dosage drug product intended for commercial distribution;
- Knowledge of performance measures and Quality Improvement Statistical tools, preferred;
- Demonstrated ability in exercising superior judgement and working independently with minimal supervision and/or guidance;
- Effectively adopt systemic approaches 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 in the organization;
- High level of professionalism and collaboration in team, cross functional and sub-teams settings;
- Ability to travel to vendor sites (up to 40%) depending on business needs;
- Successful experience in fast-paced entrepreneurial environment;
- Fit with Adamas culture and values.