Quality Sr. Manager Operations
Qualitest Pharmaceuticals - Charlotte, NC

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The Senior Manager Quality Operations is responsible for the quality oversight of all in process and product release manufacturing activities at the site; also responsible for compliance to regulations and company procedures pertaining to pharmaceutical manufacturing and packaging processes. Leads identification of continuous improvement needs and support Quality CI projects.Key AccountabilitiesManages and prioritizes workloads and projects to ensure effective and efficient completion of departmental objectives.Coordinates and collaborates with other quality, engineering, and manufacturing and packaging operations functions to oversee all quality aspects of manufacturing and packaging activities at the site including, but not limited to, Quality floor activities, and event rapid response and CAPA investigations.Coordinates and collaborates with other quality, engineering, and manufacturing operations functions as needed to implement improvement and ensure quality standards are in place.Supports product transfer activities. Manages and prioritizes product release activities to ensure compliant and timely product disposition and release.Collaborates and coordinates planning activities across Operations, Planning, Supply Chain, and the Quality Laboratory to support product release.Monitors and drives improvement of Right First Time (RFT) metrics related to manufacturing batch record entries during production.Ensures a Quality Batch Release certification process for all Quality product release staff.Assures compliance to U.S. GMPs (21 CFR 210/211) regulations.

Maintains the Quality Operations area in an inspection ready state.Assesses compliance level of direct reports and overall operation through auditing.Proactively ensures relevant SOPs reflect current practices and are in compliance with FDA and other regulatory requirements and guidances.Collaborates with other sites to ensure continuity of manufacturing compliance standards.Provides support as needed during regulatory inspections, audits and regulatory filings related to manufacturing and product release activities; develops and monitors appropriate CAPA plans. Responsible to ensure timely and adequate responses to any audit/inspection observations relative to QA Operations; ensure corrective action is implemented and evaluated for effectiveness.Selects, develops, and motivates and retains qualified Quality operation staff to effectively carry out Quality Operation functions within the Value Stream Organization (VSO), and provide for the continuity of managerial and specialized skills.Recognizes and rewards employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee moraleIdentifies the developmental needs of others and provides coaching, mentoring, and encouragement to help others to improve their knowledge or skills.Communicates new regulations, Regulatory/FDA initiatives, and current Quality & Compliance approaches.QualificationsEducation & ExperienceA Bachelor's degree in engineering, chemistry or other science is required. A Master's degree is preferred.A minimum of 10 years of Pharmaceutical/GMP experienceAt least 3 year in a management role is required. Quality Operations experience, and Green Belt or Black Belt Certification is desirable.KnowledgeKnowledge of FDA, GXP, ICH, ISO and GAMP regulations and industry best practices.Excellent knowledge of manufacturing operations in a solid dosage manufacturing facility.Strong leaderships, team building, and 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).Demonstrated skills in project management and facilitation.Ability to organize, prioritize work in the face of shifting demands and tight deadlines.Detail oriented, able to work independently and work well in a team environment.Demonstrated understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, etc.Clear problem-solving and decision-making skill.Skills & AbilitiesStrong written and verbal communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization is required.Experience in technical writing, including requirements gathering, is required.Possess the ability to make quality decisions within tight time constraints.Ability to create positive working relationships with internal and external customers to effectively manage and balance conflicting objectives and support negotiations.Ability to lead, manage and participate on teams with shared responsibility for outcomes and decision-making.Experience interviewing and assessing candidates for pharmaceutical company positions.Demonstrated proficiency at a baseline level with MS Office Suite including MSWord, MSExcel, MSPowerPoint, and MSAccess is required.

Working knowledge and hands-on experience with MSProject, MSVisio and a statistical program is a plus.Physical RequirementsLift 15 lbsAbility to wear PPE/gowning for extended periods of timeAbility to climb stairsWalk across plant/warehouseBusiness travel (10% of time)

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