Manager, Clinical Quality Services

In support of and under the direction of the Director of Clinical Quality Services, the Manager, Quality Clinical Services helps to plan, direct, and coordinate the Quality activities of a designated Clinical Customer Focused Team to ensure that the goals and objectives of the team are accomplished within the prescribed time frames and within budget. This role will supervise, empower, coach, develop and help to retain a team of qualified individuals including Quality Specialists and Quality Inspectors while partnering with the PCI-Boston Clinical Project Management team(s) to ensure that we deliver a quality product / service on time. This role will help to ensure project success through active leadership to provide PCI a competitive advantage in long-term quality customer management.

Responsibilities

Supervise, empower, coach, develop and retain a team of qualified individuals; Establish quality team and individual goals and objectives aligned with Clinical Customer Focused Team goals and customer requirements; Ensure strong alignment and coordination with other PCI business units and functional groups; Facilitate daily quality team performance to ensure goals and objectives are met; Manage training and development of the quality team including cross training and onboarding; Provide support for customer audits, visits and conference calls; Assist with investigations and corrective actions to address customer complaints, CAPAs, NMR issues; Collaborate with team members to manage team performance metrics and customer scorecards; Manage, coordinate and report on corrective and preventive maintenance activities for PCI-Boston assets; Manage, coordinate and report on calibration activities for PCI-Boston IM&TE assets; Manage, coordinate and report on qualification and validation activities at PCI-Boston; Provide day-to-day supervision of team staff

Requirements

Bachelor’s Degree in a related field and/or 3-5 years related experience and/or training; College Level Mathematical Skills; Advanced Computer Skills; Full Professional Proficiency; High Reasoning; Working knowledge of calibration, preventive maintenance and validation cGMP compliant processes and programs

Nice to have

Experience with project management

Benefits

Eligibility for an annual performance bonus; Paid time off; Health insurance coverage (including dental and vision); Flexible spending account; 401(k)