PCI Pharma Services · 14 hours ago
Manager, Quality Clinical Svc
Rockford, IL
Full-time
Onsite
Mid, Senior Level
$78K/yr - $87K/yr
7+ years expPCI Pharma Services is dedicated to creating life-changing therapies with a global impact. The Manager of Clinical Quality Services will oversee daily operations of the Clinical Quality Operations and Documents Departments, ensuring quality standards are met and leading a team to drive continuous improvement and project success.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands
Provide 24-hour support for Quality related issues either by phone or email
Be observant of processes, performance, and behaviors, focusing on continuous improvement
Manage budgets and plans for business growth
Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First Time metrics)
Provide support via emails, phone, conference calls, Quarterly Business Review/meetings, tours, audits and investigations
Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues
Ensure Quality issues are resolved appropriately and report results to Quality and Production Management
Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards
Investigate root causes of quality events/defects and recommending solutions
Manage non-conforming product, materials and reports (NMRs, Product HOLDs, Line Clearance Failures)
Manage Batch Record Right First Time program
Ability to partner and collaborate with functional departments
Primary Quality Contact for Project Management regarding operational issues
Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments
Lead and drive improvement / harmonization initiatives across multiple facilities
Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion
Report and escalate to Senior Management of any potential risks that impact Quality
Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition
Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments
Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements
Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Clinical Quality Managers and leadership
Facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement
Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc
Collaborate with the other team members to manage the team performance metrics and customer scorecard
Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the customer Quarterly Business Reviews
Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
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 Manager/Supervisor
Deliver MRO parts to PRTs on the lines in a timely fashion. Create Work Orders to document repair, time and parts issued
Assist in determining needed parts that are not stocked, coordinate expedited delivery if necessary. Determine appropriate stocking levels
Work with vendors on parts that need recoating/re-rubbering/repairing. Also work with vendors who accept old parts as trade in. Coordinate with radio vendor on repairs/warrantied work. Ensure scrap material is picked up in a timely manner
Make vinyl, and engraved signs per internal customers instructions. Maintain stock levels of all needed sign supplies. Make Asset Tags as requested
Assist in receiving stock items with entry to system, replenishment of shelves
Perform routine spare parts cycle counting on a weekly basis
Perform Maintenance and repair on gearboxes, glue nozzles and other repairable equipment. Coordinate with Machine Shop on sharpening of all blades
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
Qualification
Required
Bachelor's Degree in a related field and/or 7-10 years related experience and/or training
Statistical and Advanced Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and 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
Preferred
Project Accomplishment Experience
Benefits
Paid time off
Health insurance coverage (including dental and vision)
A flexible spending account
A 401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase