Manager, Quality Control

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. This position is responsible for the daily QC oversight of PCIu2019s laboratory functions. This includes all operational and technical activities in delivering quality chemical, biopharmaceutical and microbiologic testing services to our customers. This position oversees core activities such as in process testing and micro testing. The role includes oversight of raw material, in process, and reviewing release testing of GMP products to support our clients, interacting with Clients concerning project specific QC issues, approving department cGMP documents, contributing to cGMP reports, and managing QC staff as necessary to achieve these tasks. . ESSENTIAL DUTIES AND 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. QUALIFICATIONS: Required: + u200bBS 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: + u200bPrior 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 #LI-RS1 Join us and be part of building the bridge between life changing therapies and patients. Letu2019s talk future ( 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 companyu2019s 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 u2013 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._ 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 donu2019t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Created: 2026-02-05