Description Scope of Authority Manages the Quality Systems at his / or her site as well as metrics, but may also assist other sites with metrics on an as needed basis Key Accountabilities Accountability Responsibilities of Time Continuous Improvement Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings Compliance Assesses risk level associated with NCRs, notifies Planning / Scheduling, and escalates to management Reviews or approves Site Quality Reviews of complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours Attends meetings as requested in place of the Manager Quality Systems and determines priorities and makes appropriate decisions Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time Reviews current Quality Systems, works with cross functional teams and recommends improvements Management Review Coordinates and prepares metrics and materials for Quality Council and Management Review Continuous Improvement Performs and evaluates CAPA effectiveness checks Total 100% Qualifications Education & Experience BA / BS preferably in life sciences plus a minimum of 6+ years’ experience in the pharmaceutical industry OR MS +4 years’ relevant experience in pharmaceutical industry Knowledge Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines Technical and quality background related to pharmaceuticals Skills Abilities Strong communication skills Strong focus on quality and proven ability to apply a high degree of integrity Customer / Stakeholder focused (understand business plans and operating environment) Technical Writing ability Clear problem-solving and decision-making skill Physical Requirements Walk across plant / warehouse EEO Statement : At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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