Tarrytown, NY 10591 US
- Serve as the main point of contact for quality matters related to assigned brands and contractors.
- Develop QA strategies for assigned brands by analyzing product requirements, regulatory concerns, and stability options. Present corrective plans and implementation timelines to cross-functional teams.
- Supports new product introductions from an operational perspective.
- Reviews and approves documentation associated with the introduction or transfer of a new or existing product to contractors including stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports.
- Ensures that product dossiers are maintained and current.
- Conduct audits to assess contractor quality systems for cGMP compliance and suggest improvements. Escalate serious issues to leadership.
- Coach contractors to address deficiencies in their quality systems.
- Defines the quality obligations and responsibilities of contractors by preparing, negotiating, and reviewing quality agreements.
- Assures the quality of commercial product by reviewing and approving contractors’ change controls, deviations, nonconformances, and out of specification investigations. Initiates and conducts internal change controls, planned deviations, and investigations where applicable.
- Collects, analyzes, and prepares summary reports of regulatory and compliance data and trends such as stability, complaints, nonconformance reports, deviations, investigations, CAPA for annual product reviews.
- Protects competitiveness by keeping company information confidential.
- Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments, attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, and participating in professional societies.
- Accepts ownership for accomplishing new and different requests; explores opportunities to add value to job accomplishments.
- a BS in a scientific discipline; Masters preferred
- 5-10 years' QA experience in pharmaceutical or medical devce industry with a thorough knowledge of quality systems, quality assurance, and quality control in a cGMP environment.
- Experience leading and managing cGMP audits
- Analytical skills, sound decision-making processes and scientific problem-solving capabilities based on facts, data, and the application of risk management principles
- Ability to multitask, manage projects simultaneously and work independently
- Effective verbal and written communication skills; demonstrated interpersonal skills
- High proficiency in computer skills, Microsoft Office/Project.