Responsible for establishing and managing the Quality Assurance programs in support of theManufacturing business. Serves as a member of the Quality and Compliance management team.Provides direction in implementing our clients Compliance Program and coordinates with peers topromote consistency in quality assurance operations, regulatory interpretation, and processes. Works with the operational teams to assure regulatory compliance and consistency with our clients policies and procedures.ESSENTIAL DUTIES AND RESPONSIBILITIES:• Establish and manage the Quality Assurance program in support of client site, ensuringcompliance and harmonization with policies and procedures.• Develop and maintain all required SOP's, documents, forms, and documentation required tosupport business operations.• Communicate all identified compliance and quality risks to his/her supervisor.• Develop quality assurance policies and procedures to assure applicable regulatoryrequirements are fulfilled• Identify the need for, and assist in the development of, Corporate and Business Unit Qualityand Compliance Policies.• Manage Quality Assurance operational groups to assure inspections and audits are accurate,thorough, timely, and provide the correct interpretation of regulatory requirements andcorporate policies.• Assure staff receives appropriate regulatory and management training and mentoring to enablethe execution of regulatory and management responsibilities.• Assume a lead role in the development and presentation of regulatory training for QualityAssurance and operations staff.• Monitor the effectiveness of subordinate personnel in managing compliance systems andassuring the timely completion of: (1) review and approval of records and reports; (2)inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, andcontrols; and (5) Regulatory Affairs and Compliance projects and programs. Identify andresolve any scheduling conflicts and program priorities to assure timelines are fulfilled.• Monitor the effectiveness of subordinate Quality Assurance personnel in reviewing QualityAssurance reports of audits and inspections to assure proper and consistent interpretation ofregulatory requirements and corporate policies. Identify and resolve inconsistencies betweenQuality Assurance audit teams should they occur.• Assure that all records and reports are prepared, communicated, and retained in accordancewith applicable regulatory requirements.• Serves as a liaison with operations managers to identify regulatory deficiencies, explain auditfindings, resolve conflicts, and consult on corrective and preventative actions.• Assemble, evaluate, and report group metrics measuring compliance and quality keyperformance indicators.• Represent the corporation during regulatory and client inspections/audits• Prepare site/operation personnel for client and regulatory audits and prepare appropriatesummaries and reports of such audits.• Lead the preparation of regulatory and client audit responses and corrective actioncommitments.• Monitor site/operation corrective actions commitments and communicate "at risk" commitmentsto management with recommendations for their timely resolution.• Identify practices, methods, and processes for improvement and assist other operations onrelated compliance issues.• Assure vendors and suppliers identified/designated are assessed for the compliance withapplicable regulatory requirements.• Participate in Quality and Compliance projects and programs.• Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings,intranet communications, and relevant strategic planning sessions.• Assure that Corporate Quality and Compliance Policies are implemented and administered atthe site/operation.• Direct activities of assigned group(s) to ensure optimum performance of the group/function.• Responsible for personnel management activities such as: scheduling, personnel actions(hiring, promotions, transfers, etc.), training and development, providing regular direction andfeedback on performance, disciplinary actions and preparing and delivering annualperformance and salary reviews.• Develop short- and long-range operating objectives, organizational structure, staffingrequirements and succession plans.• Integrate activities with those of other major organizational units (e.g., segments, departments,functions).• Develop and recommend departmental budget and authorize expenditures.• Develop and oversee the implementation of departmental training programs, includingorientation.• Ensure adherence to pertinent regulatory requirements and to departmental policies, practicesand procedures (SOPs, safety procedures and biosafety protocols).• Communicate all identified compliance and quality risks to his/her supervisor.• Performs all other related duties as assigned.QUALIFICATIONS:• Education: Bachelor's degree (B.A. /B.S.) or equivalent. Advanced degree in biologicalsciences, pharmaceutical sciences, or computer sciences preferred.• Experience: Minimum of Seven years related experience in the GMP pharmaceutical and/orbiotechnology-based industry, with a minimum of 3 years of managerial experience• An equivalent combination of education and experience may be accepted as a satisfactorysubstitute for the specific education and experience listed above.• Strong experience and direct responsibility for management of Quality Assurance programsand creating new programs and processes.• Experience with direct management of QA audits and inspections as well as interfacing withclients and regulatory agencies and preparing/reviewing responses to any inspectional findings.• Strong knowledge of pertinent national and international regulations pertaining to thepharmaceutical and biotechnology industries.• Strong knowledge of computerized system compliance, validation, and data integrityrequirements.• Demonstrates strong leadership ability, communication, and facilitation skills with both internaland external client personnel.• Skilled in process optimization and continuous improvement