Center Quality Manager Job Description: Position Summary To assist in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review. Essential Functions (ES) and Responsibilities • Assures the Donor Center(s) complies with all applicable state, federal, and European Union guidelines. • Direct responsibility for the day-to-day activities, evaluation, and training of the Quality Assurance Specialist. • Authorizes the release of final product and has the authority to stop shipment of any product that does not meet compliance or customer specifications. • Assures accurate labeling and documentation of shipments. • Assures center maintains state of readiness for regulatory and customer audits. • Responsible for tracking and trending errors, corrective actions, and the approval of preventative action. • Reports compliance status to Center Management and Regional Manager, Quality Assurance routinely. Job Responsibilities or Job Requirements Competencies Maintaining Objectivity Written and oral communication skills Outstanding interpersonal, verbal, and written communication skills - must be able to translate technical concepts into non-technical terms for both senior level management and frontline staff Strong organizational, interpersonal and collaborative skills Use independent judgment to assess compliance with regulatory requirements and SOPs Develop data systems and ETL pipelines to provide data outputs that meet business needs and objectives Develops, implements, and maintains Key Performance Indicator reports for organization, including all donor sites Develops targeted data extraction within report template(s) to assist departmental needs Identifies resourceful solutions to enhance the electronic systems Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures Must have excellent writing and oral skills Must have thorough knowledge of Oracle, SQL, and Jaspersoft studios Must be able to prepare, deliver spreadsheets, data analysis, presentations and facilitate for small and large groups Excellent problem-solving and analytical skills and be able to frame issues clearly for less technical colleagues and customers Must be able to read, understand, and implement programs based on technical regulations and manuals Must have a strong customer service orientation and able to work well under pressure while interfacing with all levels of personnel, and consultants Ability to train and motivate employees at all levels within an organization Knowledge of all Federal and State regulations including OSHA and CUA Must be project oriented, creative, and computer literate Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project) Good mechanical aptitude and knowledge of general maintenance Individual must have the knowledge and experience to operate and maintain the facility and production systems, and associated equipment: high pressure steam, fuel oil, chilled water, low temperature coolant, nitrogen, compressed air, pretreatment water, water for injection, air handlers, condenser water, heating hot water, ethanol, emergency power, industrial waste, controlled environment areas Possess time management skills and be able to balance multiple job assignments at once Ability to read and understand blueprints Knowledge of instruments and electronics would be helpful to assist in the calibration and repair of control devices PC and financial accounting systems knowledge with spreadsheet and word processing applications. Ability to compose reports, follow technical manuals, communicate effectively and persuasively in business discussions Ability to effectively manage staff. Ability to handle multiple priorities and tight deadlines. Understand concepts, requirements, and accounting issues for all business areas Frequently make decisions restricted only by organization wide policies or by interpreting those policies Able to work in high-pressure, deadline-driven environment Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs Oversees execution, documentation, and review of internal and external audits Actively provides feedback to operations management and staff regarding staff performanceagainst SOPs. Works to develop and maintain a collaborative and effective workingrelationship with operations management Responsible for ensuring the center meets all regulatory and quality timelines as establishedin SOP documents Knowledge of global cGMP regulations; 21 CFR Parts 210, 211, 600, 610 and 820, ICH Guidelines, and IQPP Standards Computer proficient with intermediate skills in office programs Skills SAP HCM SKILL SAP Payroll Configuration SAP Security Knowledge FDA Adherence ADMA Bio Managing Time Protein Biochemistry, especially immunoglobulin chemistry Protein purification Process Development Scaling of processes from the bench scale to commercial manufacturing Statistical analysis Must be independent and able to design experiments, processes, thinking critically with vision, and is responsible to analyze data and make recommendations to senior management regarding process improvements and development Basic computer skills Maintains a professional appearance and demeanor when interacting with peers and donors Maintains competence with all position required tasks Demonstrated ability to use computer software including MicroSoft Outlook, Word and Excel. Ability to understand and interpret government regulations and customer specifications Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations Ability to follow the cGMP's and procedures with great attention to detail Demonstrated ability to work well with people from diverse backgrounds Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Exceptional organizational and communication skills required Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities. Good mechanical aptitude and knowledge of general maintenance. Basic computer skills including experience with software programs such as Word, Excel, and GroupWise Experience Requirements • Ability to follow the cGMP's and procedures with great attention to detail. • Demonstrated ability to use computer software including Microsoft Outlook, Word, Excel, and PowerPoint. • Ability to understand and interpret government regulations and customer specifications. • Ability to drive for extended periods (a minimum of four hours at a time). • Ability to drive or fly to company/industry meetings or training. • Available to work extended shifts and weekends. • Ability to lift, pull, or tug up to 40lbs. • Work requires extended periods of standing and bending. • Potential exposure to blood borne pathogens. • Ability to work in a cold environment, -30°C, for short periods of time. Education Requirements • Bachelor's degree or equivalent professional experience. Preferred Experience Compliance Requirements (ES) • Has the responsibility to report any deviations (GMP) or regulatory practices to the Regional Manager,Quality Assurance. • Assures that SOPs, policies, and practices are updated and validated as applicable and that staff is performing in accordance with SOPs through scheduled audits and direct performance observations.