​​In supportofand under the direction of the Director of Clinical QualityServices​, the Manager, QualityClinicalServices helps toplan, direct,andcoordinatetheQuality activities of a designated Clinical Customer Focused Team toensurethatthegoals and objectives of the team are accomplished withintheprescribed time frames andwithinbudget.This rolewillsupervise, empower, coach, develop andhelp toretain a team of qualified individualsincludingQuality Specialist(s) and Quality Inspector(s)while partnering with thePCI-BostonClinical Project Management team(s) to ensurethat we deliver a qualityproduct serviceon time.This role willhelp to ensureproject success through active leadership toprovidePCIa 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 responsibilitiesincludethefollowingbut other duties may be assigned.

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

• Help toestablishquality team and individual goalsandobjectivesthat are aligned withClinical Customer Focused Team goals and customer requirements.

• Ensure strong alignmentand coordination with other PCIbusiness unitsand functional groups Collaborate on “best practices” withother Clinical Quality Managers and leadership.

• Facilitate daily quality team performance to ensureallgoals andobjectivesaremet 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 andonboardingof new employees to the team.

• Providesupport for customer audits,visitsand conference calls. Work with the PCI-BostonClinical Customer Focused team tohelp conduct deviation investigations and corrective actions.Assistwithinvestigations and corrective action(s) to address customer complaints, CAPAs, NMR issues, etc.

• Collaborate with team members to manageteam performance metrics and customer scorecards. Collaboratewith Business Development and the Project Management teamsto help coordinate andfacilitatecustomer Quarterly Business Reviews (QBRs)

• Manage, coordinate and report onthestatus andcompletion ofall corrective and preventive maintenance activities forPCI-Boston assetsBe the primary point of contactfor PCI-Boston’s maintenance program & process.

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

• Manage, coordinateand report on the status and completion of allqualification and validation activitiesat PCI-Boston as per the site Master Validation Planand related SOPs andWIsThis includes periodic revalidation activities,temperaturemappingand initial qualification activities associated with new installations ofequipment, i.e., freezers, LN2 units, etc. Manage the change control process for these activities.

• Knowledge of, and adherenceto PCI and cGMP policies, procedures,rulesand regulations.

• This positionmay require overtime, and / or weekend work.

• Attendance to work is an essential function of this position

• Performs other duties asassigned by the site Director of Clinical Quality Services

• Provides day-to-day supervision ofteam 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, andor abilityrequiredfor the stated position. Reasonableaccommodationsmay be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor’sDegree in a related field and / or3-5yearsrelated experience and / or training.

• ​​College Level Mathematical Skills​

• AdvancedComputer SkillsAbility to performthe mostcomplex computer tasks andtooperatevarious computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on alllevelspertinent 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 andvalidationcGMP compliant processes and programs

Preferred:

• Experience withproject management.