Manager, Clinical Quality Services

About this role

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.     Position Title: Manager, Clinical Quality Services Location: Bridgewater, MA Department: Clinical Quality Shift:  First Shift Reporting To: Director of Clinical Quality Services Supervisory: Yes

​ ​ In support   of   and under the direction of the Director of Clinical Quality   Services ​ , the Manager, Quality   C linical   Services helps to   p lan, 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 Q uality Inspector(s)   while partnering with the   PCI-Boston   Clinical Project Manage ment 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 in dividuals 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 action s.   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 a dherence   to PCI and cGMP policies, procedures,   rules   and regulations.  

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

• A ttendance to work is an essential function of this position .  

• Performs other duties a s   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.    

​​

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   v alidation   cGMP compliant processes and programs .  

Preferred:

• Experience with   project management.  

The hiring rate for this position is $95,360-$107,280 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple fa

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