Acts as the Quality Assurance subject matter expert for assigned Quality Systems and product lines. This includes involvement in systems, procedures, investigations and manufacturing (current Good Manufacturing Practices) cGMP compliance as both a participant and a facilitator. This position is responsible for identification and implementation of continuous system improvements, oversight of critical quality systems as assigned and disposition of pharmaceutical products Management of Quality Systems Evaluates, updates and approves existing SOPs for cGMP compliance and compliance to corporate procedures Oversees and participates in the Change Control process including the writing, review and approval of Change Controls. Oversees and participates in the CAPA process, including writing, review, and monitoring of action items. Works with the appropriate discipline to identify change actions or corrective/preventative measures necessary for improvement and to align processes to consistently manufacture quality products. Leads and participates in Process Improvement teams. Performs trending of Quality Systems including but not limited to: Exceptions, CAPA, Change Control, Annual Product Review, Supplier Quality, and Internal and External Audits. Champions a Quality System, monitoring user activity, due dates, extensions, and content approval. Independently leads gap assessments and remediation efforts. Provides technical expertise and guidance to other team members. Identifies and mitigates risks of current practices to process, product and patient. Supports Investigations and Assesses Product Impact Writes, reviews and approves Exceptions in EQMS Reviews and Approves Out of Specification Investigations in EQMS Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail. Leads and participates in Root Cause Analysis teams Reviews and approves investigation reports to ensure it contains the appropriate level of detail and appropriate CAPA's are identified. Reviews investigations and uses process and equipment knowledge, subject matter expert input, technical documents, and risk management tools to determine potential product impact and product disposition. Support Regulatory Compliance and Strategic ANDA/NDA Filing Opportunities Assists in the compilation of eCTD submission documentation (NDA/ANDA original submissions, supplemental applications, annual report compilation packets) Assists in the compilation of international dossier documentation Participates on product and process development/transfer teams as assigned Provides technical expertise and guidance in the generation of Regulatory Strategy requests Generates Annual Product Reviews / Annual Product Risk Assessment report Supports internal and external audits and inspections. Minimum Requirements Education: Bachelor Degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies accepted. Experience: Minimum of 5 years of technical experience in a pharmaceutical manufacturing environment (including QA/QC or engineering experience). Preferred Skills/Qualifications: 34; Strong verbal and written communication skills 34; Knowledge of Quality Systems 34; Knowledge of cGMPs for Finished Dosage Products 34; Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience 34; Ability to quickly identify, communicate and/or resolve issues 34; Effective communication and leadership skills Other Skills/Competencies: 34; Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage Travel Requirements: 34; Availability to travel at least 10-20% time is required for this position. The expected base pay range for this position is $100,000 - $135,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience. Organizational Relationship/Scope: 34; Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details. 34; Written Communication: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. 34; Making Complex Quality Decisions: Can solve even the toughest and most complex of problems; great at gleaning meaning from whatever data is available; is quick study of the new and different; adds personal wisdom and experience to come to the best conclusion and solutions; uses multiple problem solving tools and techniques. 34; Managing Change: Helps employees develop a clear understanding of what they will need to do differently as a result of changes in the organization; establishes structures and processes to plan and manage the orderly implementation of change; helps individuals and groups manage the anxiety associated with significant change; facilitates groups or teams through the problem-solve and creative-thinking processes leading to the development and implementation of new approaches, systems, structures and methods. 34; Managing Performance: Establishes clear expectations, provides timely, accurate feedback - both positive and negative - and takes appropriate follow-up actions, (for example, rewarding, publicizing successes, coaching and guiding); recognizes, rewards and promotes people based on their performance, achievement of results, and development of competencies; works with individuals to identify areas for development, understand need for improvement, and set specific development goals.