**Job Title:** QO CC & CNM Senior Associate **Location: Sanford, NC** **Pay Range: DOE** **What’s the Job?** The QO CC & CNM Senior Associate ensures oversight of quality and compliance requirements throughout the product lifecycle from design through BLA submission, working in partnership with all quality organization teams, site project management, and technical transfer teams. The roles primary responsible will be to provide quality support of change management responsibilities including, but not limited to initiation, assessment, and approval. The role will support the KPI and Change Management metrics for the site as well. Key responsibilities include the review and approval of change control documentation for the site to ensure alignment with regulatory requirements for facilities, equipment, and processes; plan and execute projects with support; suggesting improvements and conduct continuous improvement activities; interfaces with and represents department in cross-functional/cross-site meetings. 1. Role responsibilities **Individual Accountabilities** : 1. Review and approve change control documentation, including impact assessments, implementation plans, and closure of records. 2. Fundamental knowledge of principles and concepts of current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards. 3. Good judgement and correct decision making based on Pfizer procedures, PQSs, technical experience; and industry guidance / regulatory regulations 4. Identify and implement new processes and programs for Quality improvement and drive projects to completion. 5. Ensure timely and compliant execution of change controls and network compliance activities. 6. Represent QA in cross-functional and cross-site meetings to resolve complex compliance issues. 7. Promote continuous improvement and proactive compliance culture across the site. 8. Ensure adherence to Good Documentation Practices and Data Integrity principles. 9. Act as a role model for Pfizer’s values and behaviors 10. Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development. 11. Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Pfizer Quality standards, policies and values in a timely manner **Shared Accountabilities** 1. Support QA teams with compliance oversight for manufacturing operations. 2. Provide quality consultation for change control and compliance-related activities across departments. 1. Education or equivalent 1. 3-5 years of manufacturing, laboratory, quality, technical, or engineering experience within biotech or pharmaceutical industry with a BS/BA Degree in Science/related field. 2. 1-3 years of manufacturing, laboratory, quality, technical, or engineering experience within biotech or pharmaceutical industry with a MS Degree in Science/related field. 3. PhD in Science/related field and 3+ years’ experience. 1. technical competencies 1. Knowledge of the principles and concepts of Good Manufacturing Practices (cGMPs) of US, EU, and ROW and Pfizer Quality Standards 2. Knowledge of quality systems and quality risk management tools 3. Interpersonal effectiveness and communication skills (written and oral) to interface across management levels and departments 4. Proactive approach and strong critical thinking skills 5. Knowledge of electronic systems including eQMS, Trackwise, PDOCs, SAP, MS Word and Excel 6. Direct experience with and/or knowledge of aseptic manufacturing procedures, technical transfer concepts, validation (i.e. process, cleaning, equipment) or compliance concepts. 1. behavioral competencies 1. Organization and time management skills to work with multi-disciplinary teams 2. Excellent communication and interpersonal skills 3. Willing to lead by example, collaborative and active listener 4. Self-motivated and capable of working with minimum direction 5. Effectively manage stress situations; able to focus on tasks regardless of circumstances and stress-induced pressure. 6. Ability to be flexible with changing priorities. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. 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