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Job Analysis:
The Project Manager / Sr. Project Manager role at ValSource is a high-responsibility leadership position focused on the management and execution of commissioning, qualification, and validation (CQV) projects within pharmaceutical, biotech, and AMTP environments. The fundamental purpose of the role is to ensure that facilities, laboratory, and manufacturing equipment and processes meet stringent regulatory and quality standards while driving projects to successful, on-time, and on-budget completion. This role demands a strong combination of technical expertise in FDA-regulated environments, project management acumen, and the ability to lead diverse cross-functional teams, often under dynamic and shifting priorities. The candidate must be adept at developing scopes, plans, and estimates and managing multiple aspects such as cost, schedule, and risk, emphasizing quality and compliance with ISPE, PDA, FDA, ICH, ISO, and EU regulations. Critical to success is the ability to translate complex validation requirements into actionable project milestones, mentor junior staff, and act as a trusted liaison with clients. Traveling to client sites and hands-on field participation during commissioning and start-ups further highlight the hands-on leadership expected. Success in this role will be measured by seamless project execution, client satisfaction, regulatory compliance, and a demonstrated ability to manage complexity and ambiguity while nurturing collaborative team environments.
Company Analysis:
ValSource is a well-established and leading independent validation services provider in North America, specializing in life sciences industries that require rigorous regulatory compliance, such as pharmaceuticals and biopharma. Their market position as a reputable subject matter expert organization—with a strong legacy since 1996—signals a stable yet innovation-driven company that deeply values scientific rigor and quality risk management. The culture likely prioritizes continuous learning, technical excellence, and adherence to best practices, given their contributions to industry guidelines and regulatory knowledge bases. For someone stepping into the Project Manager role, this means operating in a professional environment that demands both technical mastery and the ability to uphold the company's commitment to quality. The role fits into a mid-to-senior level leadership tier where the individual has significant visibility across projects and likely interacts with both clients and internal leadership. Importantly, this position feeds directly into ValSource’s strategic aim of scaling high-quality project delivery and maintaining their reputation as industry leaders in validation services. Candidates must be comfortable with a balance of autonomy and collaboration in a company culture that rewards ownership, proactive problem-solving, and technical thought leadership.