The Senior Manager, Pre-commercial Quality Assurance is responsible for managing quality operations at Adamas Contract Service Providers of clinical drug substance, drug product, packagers and distribution to ensure that CSP are in compliance with applicable regulations, Quality Agreements (QA), and Standard Operating Procedures (SOP's). In addition will provide Quality support to all Development Project Teams. This position will report to the Vice President of Quality Assurance and is based in Emeryville, CA.
Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls for the design, conduct, performance, monitoring, recording, auditing, analysis, and reporting of developmental and clinical trials data;
Ensures that performance and quality of clinical supply materials providers conform to established standards and regulatory agencies requirements;
Responsible for ensuring that quality data is collected and that the rights and well-being of the clinical trial subjects are protected Primary person for the quality oversight of clinical trial material / investigation medicinal products release to distribution including master batch record review and approval, executed batch record review, assessment of deviations, change control and analytical data for the disposition of product in support of regulatory applications and release in IRT for clinical use;
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies in support of regulatory applications and to assure compliance in all product to be used for clinical purposes;
Works directly with clinical product suppliers in conjunction with the Adamas Clinical Supplies Manager to ensure operations remain in a compliant state, and product meets all required standards and specifications;
Quality oversight responsibilities for all aspects of manufacturing, packaging, labelling, and kitting of drug product intended for use in clinical trials; including scheduled material of product to be used for clinical purposes;
Leads external quality audits for the qualification of developmental and clinical contract service providers;
Supports Adamas during audits and inspections to sites responsible for the handling of product to be used in support of regulatory submissions and in clinical studies;
Provides quality support for the development and maintenance of clinical trial protocols, clinical trial master files, clinical study reports, as well as clinical site qualification and monitoring;
Responsible to support in the Regulatory submissions of New Drug Applications (NDA)
Complies with corporate policies and procedures, as well as, US healthcare laws and regulations.
Bachelor's degree in science or related field and + 8 years of relevant hands on experience in a highly regulated pre-commercial environment;
In-depth knowledge of Pre-commercial QA principles, concepts, industry best practices, regulatory standards, and ICH Guidelines;
Experience in the all aspects of manufacturing, packaging, labelling, kitting, and distribution of oral solid dosage drug product intended for use in clinical trials; including scheduled material of product to be used for clinical purposes;
Knowledge of performance measures and Quality Improvement Statistical tools;
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 and sub-teams settings;
Extensive experience working successfully with oral solid dosage developmental and clinical contract service providers, and ensuring that regulatory standards and timelines are consistently met;
Ability to travel 40-50% of the time depending on business needs;
Successful experience in fast-paced entrepreneurial environment;
Fit with Adamas culture and values
To apply for this position please send your resume to firstname.lastname@example.org with the job title in the subject line. Principals only, no recruiters please.
Adamas is an Equal Opportunity Employer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.