Project Manager II (Associate Director Quality Capital Programs)

Project Manager II / Associate Director Quality Capital Programs 2‑Year initial contract, remote or hybrid with some on‑site in NC supporting new sterile manufacturing campus buildout in North Carolina. Hourly Pay Rate: $65‑68/hr (medical insurance benefits available at a cost). The Project Manager II / Associate Director Quality Capital Programs is responsible for providing quality assurance oversight for sterile manufacturing capital programs from early design phase through commissioning and qualification. This position acts as the primary quality representative for key capital programs and partners cross‑functionally with site, engineering, quality, operations, and technical teams to ensure GMP, contamination control, and regulatory compliance requirements are built into facility, utility, and equipment design. Responsibilities Accountable for the quality oversight at design phase and commissioning and qualification phase of sterile manufacturing capital programs in the network. Knowledge of the design principles and concepts applicable to the manufacturing processes for sterile manufacturing. Lead GMP Design Review risk assessments for capital programs ensuring contamination control and GMP requirements are assessed and mitigated. Influences the quality aspects of capital programs with a thorough understanding of regional and global regulations for GMP and contamination control requirements; drives the GMP and quality requirements for facility, utility and equipment designs ensuring any regulatory compliance and contamination risks are identified and mitigated during design phase. Participate in system risk assessments (SRAs) and review qualification documents in compliance with risk‑based qualification requirements. Determine the critical design elements impacting product quality, regulatory compliance and assess the proposed critical elements test plan to qualify the facility, utility and equipment. Standardize GMP design review templates for capital programs and integrate into the Quality System. As a member of the COE for Qualification and Validation, assess and continuously improve the Quality System supporting the capital programs, commissioning and qualification processes and procedures. Develop and integrate a process supporting the capital programs team to receive feedback from audits and inspections, and applicable regulatory compliance updates ensuring capital programs remain compliant. Establish relationships and collaborate with site project team members, engineering, engineering central services, PDS&T, Lab of the Future, Factory of the Future and other cross‑functional team members to achieve the quality deliverables. Knowledge of applicable regulations as defined by FDA, EMEA and regional ministries of health. Knowledge of quality risk management and contamination control strategies. Member of Centers of Excellence (Facility/Utility/Equipment and Qualification and Validation COEs). Qualifications Bachelor or Master’s in Microbiology, relevant Science or Engineering related discipline. Minimum 10 years relevant experience with process knowledge of aseptic manufacturing and QC Microbiology. A strong quality assurance mindset with knowledge and experience in either quality assurance, engineering, operations, or technical area with a comprehensive understanding of biological and pharmaceutical technologies. Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements. Knowledge of pharmaceutical regulatory requirements and expectations including Code of Federal Regulations, EU GMPs, EMA/FDA Guidelines, Pharmacopeia, PIC/S. Knowledge and experience with risk‑based qualification (ISPE Baseline Guide Volume 5: Commissioning and Qualification) and quality risk management (ICH Q9). Ability to work strategically, with excellent organizational skills and the ability to successfully manage multiple programs and create a high‑performance work environment. Excellent communication skills, both verbal and written. Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve them. #J-18808-Ljbffr Orion Group