Director - GLP Quality Assurance and Validation

Acorda Therapeutics is a publicly traded (NASDAQ: ACOR) biotechnology company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.

The Director – GLP QA & Validation manages and coordinates GLP regulated QA activities and validation activities for computer systems and equipment used for GLP and GMP regulated projects. This individual is responsible for independently performing domestic and international audits/inspections that ensure compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. This includes applying developed skills to assure management that the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with applicable regulations. Applies developed skills to assure management that nonclinical studies are conducted in accordance with applicable regulations. Provides recommendations for corrective action and tracks corrective action commitments until closure. The Director develops and oversees Acorda’s quality policies and audit plans for each nonclinical study and validation project. The Director also works with the Vice President – Quality Assurance to align departmental SOPs, Corporate Policies and Corporate Procedures that comprise Acorda's Quality Management System (QMS) with applicable GXP regulations, regulatory agency guidances and expectations, and industry standards. The Director also is responsible for overseeing the identification of issues and working with cross functional teams to identify appropriate corrective/preventative actions.

* Manages quality assurance activities for all in-house GLP regulated activities. * Manages qualification and provides quality oversight of third parties contracted to perform any functions in support of the GLP regulated studies or validation projects. * Plans and conducts GLP audits of GLP regulated third parties to assess compliance with all pertinent regulations as well as with company SOPs. Oversees audits of validation projects to assess compliance with all pertinent regulations as well as with any company SOPs. * Business Owner for the Acorda document management system. * Works with the Executive Director - QA to assure alignment and compliance with Acorda’s Quality Management System, support assessment of compliance and define metrics to determine performance objectives. * Collaborates with Research & Development and Clinical Operations staff to identify, evaluate, and recommend solutions to issues identified in the performance of GLP audits. * Collaborates with Information Technology or other departments, as necessary, to identify, evaluate, and recommend solutions to issues identified in the performance of validation audits. * Oversees the management of both the internal and external audit programs by assigning audits to appropriate Acorda Quality associates and helps ensure that Quality internal and external audit reports are issued in a timely manner. * Works with Acorda Senior Management to identify, evaluate, and recommend solutions to issues identified during the performance of internal audits. * Collects data from internal/external audits and reports metrics and trends in order to implement process improvements of Acorda's QMS. * Assist with internal and external training of Acorda staff and vendors. * Assists Vice President of Quality during FDA inspections. * Prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan. Conducts follow up activities as needed to monitor corrective actions. * Assists with internal GLP and 21CFR11 training. * Leads initiatives on GLP and 21CFR11 compliance and associated internal audits. * Works in conjunction with the Executive Director, QA to align SOPs, policies and procedures with Acorda’s Quality Management System. * Acts as a compliance resource to Acorda employees.

* Education and/or Experience: * Bachelor’s Degree in a scientific or health-related field required. * Master’s Degree in a scientific or health related field preferred. * Minimum of ten to 15 years Quality experience in the biotechnology or pharmaceutical industries required, of which six to eight years are in auditing and at least five are in a senior management of Quality role. * Advanced understanding of the application of GLPs, FDA regulations and ICH guidelines is required. * Supervisory Responsibilities: * The Director manages the Senior Manager, Quality Systems, Senior Manager-Archivist, Manager, Quality Validation and Manager, Quality Training, and also leads assigned cross-functional teams. * Qualifications: * Expert knowledge of GLP requirements per 21 CFR part 58 and Electronic Records and Signatures part 11. * Maintains professional expertise and knowledge of local and international regulations, by attending courses, networking with QA colleagues outside of Acorda and reading FDA guidances. * Computer Skills: * Must be proficient in MS Office Suite and QUMAS. * Certificates, Licenses, Registrations: * None required. * Other Skills and Abilities: * Good interpersonal skills, ability to interact effectively with all levels of personnel within the organization and externally with investigators and study site personnel. * Ability to review documentation, processes and procedures as it relates to clinical trial activities; to identify issues/problem areas; assess compliance; communicate findings to the clinical teams. * Excellent verbal and written communication skills. * Strong ability to prioritize tasks and keen attention to detail. * Demonstrated leadership and project management skills.