​​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 Specialist(s) and Quality Inspector(s) 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. 

Essential Duties and Responsibilities: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.  

• In support of and under the direction of the Director of Clinical Quality Services, supervise, empower, coach, develop & retain a team of qualified individuals through employee development, performance management, planning and recognition. 

• Help to establish quality team and individual goals and objectives that are aligned with Clinical Customer Focused Team goals and customer requirements. 

• Ensure strong alignment and coordination with other PCI business units and functional groups. Collaborate on “best practices” with other Clinical Quality Managers and leadership. 

• Facilitate daily quality team performance to ensure all goals and objectives are met and to help build a culture of safety, quality, performance, customer service, and continuous improvement. 

• Manage the training and development of the quality team including cross training initiatives and onboarding of new employees to the team. 

• Provide support for customer audits, visits and conference calls. Work with the PCI-Boston Clinical Customer Focused team to help conduct deviation investigations and corrective actions. Assist with investigations and corrective action(s) to address customer complaints, CAPAs, NMR issues, etc. 

• Collaborate with team members to manage team performance metrics and customer scorecards. Collaborate with Business Development and the Project Management teams to help coordinate and facilitate customer Quarterly Business Reviews (QBRs). 

• Manage, coordinate and report on the status and completion of all corrective and preventive maintenance activities for PCI-Boston assets. Be the primary point of contact for PCI-Boston’s maintenance program & process. 

• Manage, coordinate and report on the status and completion of all calibration activities performed on behalf of PCI-Boston’s IM&TE assets (Inspection, Measuring & Test Equipment). Manage the investigation(s) associated with any instances of OOS (Out of Specification) results identified during calibration activities. 

• Manage, coordinate and report on the status and completion of all qualification and validation activities at PCI-Boston as per the site Master Validation Plan and related SOPs and WIs. This includes periodic revalidation activities, temperature mapping and initial qualification activities associated with new installations of equipment, i.e., freezers, LN2 units, etc. Manage the change control process for these activities. 

• Knowledge of, and adherence to PCI and cGMP policies, procedures, rules and regulations. 

• This position may require overtime, and / or weekend work. 

• Attendance to work is an essential function of this position. 

• Performs other duties as assigned by the site Director of Clinical Quality Services. 

• Provides day-to-day supervision of team staff under the direction of the site Director of Clinical Quality Services.  

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Qualifications:

The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Required: 

• Bachelor’s Degree in a related field and / or 3-5 years related experience and / or training.  

• ​​College Level Mathematical Skills​ 

• Advanced Computer Skills: Ability to perform the most complex computer tasks and to operate various computer programs.  

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.  

• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.  

• Working knowledge of calibration, preventive maintenance and validation cGMP compliant processes and programs. 

Preferred:

• Experience with project management.