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PCI Pharma Services

Manager, Clinical Quality Services

Bridgewater, MA, United States

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Job details

Posting language: English
Posted: Aug 6, 2026

Original job description

Bridgewater, MA, USA

Full time

JR118753

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 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 &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 assets.Be 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 andWIs.This 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.

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’sDegree in a related field and / or3-5yearsrelated experience and / or training.
College Level Mathematical Skills
AdvancedComputer Skills:Ability 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.

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 factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

IF YOU ARE A RESIDENT OF MASSACHUSETTS OR APPLYING FOR A JOB IN MASSACHUSETTS PLEASE READ:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

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More about this job

Skills

Leadership
Performance management
Customer service
Process improvement
Training and development
Sales
Project management
Preventive maintenance
Inspection

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