PCI Pharma Services · 15 hours ago
Manager, Quality Control
Madison, WI
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies with a global impact. The Manager, Quality Control is responsible for overseeing daily QC operations, ensuring compliance with regulations, and managing QC staff to deliver high-quality testing services.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Provides Quality Control oversight of all cGMP testing of raw materials, in process, product release, clean utility and environmental monitoring testing. Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories
Maintains good relations and communications with clients as a primary technical interface
Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel
Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes
Leading customer interaction on all QC related projects including routine testing updates
Manage and develop professional and technical skills and performance of department members
Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary
Supporting regulatory information requests from customers as it pertains to QC. Supporting Operations, Project Management Staff and Quality Assurance as needed
Drive technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance
Demonstrate substantial knowledge of subject matter, industry best practices and trends
Other tasks as assigned by management
Qualification
Required
BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred
5+ years of Pharmaceutical or Biotechnology industry experience
Experience in leading a commercial, aseptic drug product quality control team
5+ years previous QC management experience
Quality leadership experience working on cross-functional teams to harmonize operational, testing and compliance processes
Experience in the Management of +5 people
Preferred
Prior experience in a CMO or dealing with CMOs preferred
Demonstrates excellent verbal, written, and interpersonal communication skills
Demonstrated ability to perform in a fast-paced environment
Highly developed leadership capabilities to motivate and inspire teams
Independently motivated, detail oriented and good problem-solving ability
Demonstrates a strong customer service orientation with effective follow through
Driven to excellence while encouraging others to engage in process improvement and innovation
A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members
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
unknownKey Investors
Bain Capital,Kohlberg & Company
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase