Jobs at PCI Pharma Services

Provides strategic and operational leadership for Quality across a biopharmaceutical development and manufacturing campus. Oversees QA, QC, validation, QMS, regulatory compliance, inspection readiness, patient safety, manufacturing quality, audits, investigations, batch disposition, supplier quality, quality agreements, budgeting, and regulatory agency interactions. Leads quality strategy, continuous improvement, talent development, succession planning, and cross-functional initiatives while ensuring compliance with global cGMP and related regulations.

Leads security infrastructure and guard force operations across PCI facilities. Develops security policies, oversees access control and surveillance systems, manages internal and contract security staff, coordinates investigations and background checks, and serves as the primary contact for regulatory and law-enforcement security matters. The role manages security budgets, audits, compliance, emergency protocols, and facility security improvements, with occasional travel and possible overtime or weekend work.

The Human Resources Manager partners with site and operations leadership to execute HR strategies, manage talent and employee relations, support organizational development and change, ensure employment compliance, and promote engagement and inclusion. The role also manages labor relations, collective bargaining agreements, grievances, and dispute resolution; analyzes workforce metrics; coaches leaders; and contributes to ESG initiatives. This is an on-site position with occasional multi-site travel.

Manages validation projects for large customer accounts, including preparing and executing protocols, master validation plans, validation statements, change controls, and audit documentation. Investigates deviations, coordinates corrective actions and approvals, reviews customer standards, supports process and cleaning validations, and serves as a customer contact. Ensures compliance with cGMP, GCP, GAMP, 21 CFR, and Annex 11 requirements. The role may require overtime and weekend work.

Manages clinical packaging projects from planning through completion, ensuring timelines, budgets, quality standards, and customer expectations are met. Serves as the primary customer contact, leads project teams and kickoff meetings, reviews clinical protocols and packaging specifications, manages scope and invoicing, supports quotations, and oversees risk mitigation. Coaches clinical project managers, facilitates lessons learned, hosts customer visits, and supports strategic improvement initiatives. Travel of 10–30% is required.

Supports pharmaceutical customer project execution and order fulfillment by managing production schedules, forecasts, procurement requests, ERP work orders, materials, documentation, inventory, releases, shipment preparation, and delivery metrics. Coordinates with procurement, quality, production, customers, and project teams to resolve issues, maintain compliance with cGMP and GCP requirements, and ensure timely, accurate fulfillment within budget.

Develop and execute indirect procurement category strategies, analyze spend and markets, manage supplier relationships, lead sourcing and negotiations, mitigate risk, monitor performance, and integrate ESG goals. The role collaborates cross-functionally and with site procurement teams, mentors team members, and uses analytics and procurement software to drive savings, compliance, innovation, and supplier performance. This is a remote position with occasional travel.

Manage accounts receivable and credit control activities, including customer credit reviews, collections, receipt allocation, invoicing, credit notes, dispute resolution, aged debt reduction, bank reconciliations, and month-end close. The role supports management accounts, intercompany reconciliations, sales ledger maintenance, and finance projects across PCI sites. It requires strong Excel skills, accuracy, numeracy, organization, communication, confidentiality, and compliance with company procedures, GDPR, GMP, and regulatory guidelines.

Leads pharmaceutical process development projects involving formulation, sterile filtration, lyophilization, high-potency compounds, biologics, analytical testing, scale-up, and technology transfer. Develops processes and regulatory strategies, troubleshoots laboratory challenges, authors controlled documentation, supports client communications, and mentors junior scientists. Collaborates with Quality, Manufacturing Technical Services, Operations, and external clients while ensuring cGMP compliance and project execution.

Supports pharmaceutical process development through formulation and process design, laboratory testing, sterile filtration, lyophilization, scale-up, technology transfer, and manufacturing transition activities. Performs analytical testing using HPLC/UPLC, spectroscopy, titration, and thermal analysis techniques. Prepares batch records, protocols, reports, and SOPs, maintains laboratory equipment, collaborates with QC, manufacturing, operations, and clients, and provides technical project updates.

Leads continuous improvement initiatives in biopharmaceutical manufacturing using Lean and Six Sigma methods. Analyzes operational data, identifies waste and process variability, coaches process owners, and drives improvements tied to facility KPIs. Responsibilities include developing SOPs and training materials, auditing new and existing processes, reviewing batch records, supporting validation, conducting training, and partnering with cross-functional teams to improve efficiency, quality, capacity, safety, and cost performance while adhering to PCI, cGMP, and GCP requirements.

Supports pharmaceutical quality assurance activities, including medicinal product certification and release, GMP compliance, audits, deviations, CAPA, change controls, investigations, document control, validation, and quality-system improvement. The role assists the Qualified Person, assesses batch records and temperature excursions, prepares draft certification documentation, delivers GMP training, and supports client and internal audits. Strong communication, project coordination, decision-making, and pharmaceutical quality experience are required.

Leads QA Compliance activities for PCI Pharma’s clinical and commercial manufacturing facilities. Manages audit and inspection readiness, risk management, deviations, CAPA investigations, quality event metrics, QMS improvements, regulatory compliance, vendor and customer audits, and quality provisions in client agreements. Directs, coaches, and develops the QA Compliance team while ensuring adherence to FDA, international, and cGMP requirements.

Leads pharmaceutical and medical device manufacturing operations, including aseptic processing, formulation, filling, lyophilization, cleanroom activities, staffing, scheduling, safety, documentation, investigations, CAPAs, validation, training, inventory, budgets, and audit readiness. Collaborates with Quality, Facilities, Validation, Project Management, and senior leadership to maintain cGMP compliance, improve processes, support product development, and meet production timelines.

Provides administrative support to the Customer Operations department, including JDE account and item setup, bills of materials, delivery bookings, collections, packing lists, sales orders, order acknowledgments, billing coordination, and obsolete material destruction. The role requires prioritization, problem solving, collaboration, Microsoft Office proficiency, adherence to SOPs and GMP, and flexibility across shifts.

Manages customer projects from planning through completion, ensuring delivery within agreed timelines, budgets, specifications, and regulatory requirements. Serves as the primary customer contact, leads project teams and meetings, manages expenses and billing, reviews packaging specifications, supports contracts and quotations, and oversees customer communications. Supervises and mentors Associate Project Managers, coordinates customer visits, supports continuous improvement, and ensures adherence to PCI, cGMP, and GCP policies.

Supports clinical customer projects by coordinating documentation, material receipt and release, production schedules, shipments, billing, inventory, and customer communications. Ensures project activities meet timelines, budgets, customer expectations, and pharmaceutical regulatory requirements. Resolves operational issues within cGMP and GCP guidelines, assists Project Managers, participates in customer calls and visits, supports project setup and closeout activities, and helps train new employees.

Provides strategic and technical leadership for site microbiology programs supporting cGMP sterile manufacturing. Oversees environmental monitoring, microbial testing, contamination control, aseptic practices, investigations, quality systems, regulatory compliance, audits, validation, and continuous improvement. Leads staffing, training, performance management, budgeting, and cross-functional partnerships with Quality, Manufacturing, Engineering, Validation, clients, and regulators.

Supervise mechanical personnel supporting pharmaceutical packaging operations. Coordinate equipment setup, repairs, preventive maintenance, production-driven staffing, overtime, spare parts, and line readiness. Train and coach mechanics, manage assignments, maintain payroll and work-hour records, investigate issues, and ensure compliance with GMP, FDA, DEA, OSHA, safety, and company procedures.

Provides engineering support for biopharmaceutical manufacturing facilities, utilities, process equipment, capital projects, commissioning, qualification, validation, troubleshooting, and continuous improvement. Leads critical and plant utility projects from concept through closeout while ensuring compliance with cGMP, EH&S, FDA, and site quality systems. Collaborates with manufacturing, quality, automation, maintenance, contractors, and other functional teams on equipment specifications, procurement, installation, FAT, SAT, startup, and lifecycle documentation.