guide investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
support team in tracking to deviation closure deliverables to meet lot disposition timelines
improve the technical capabilities and quality practices within the department
coordinate activities and resolve issues across the department, other groups, and/or projects
ensure response to and/or resolve recurring technical or processing issues
drive safety, quality and accountability culture
communicate information effectively through updates, reports, and summaries
lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
participate directly in internal, external, and global health authority audits/inspections
apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
establish goals of the department
assist in providing leadership on project teams
provide routine updates on progress, status, and issues associated with campaigns/projects
provide support and/or direction to junior staff when necessary
exercise sound judgment when making decisions
make critical decisions in collaboration with key stakeholders
demonstrate accountability for personal, departmental, and organizational initiatives

BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering)
minimum 10 years of experience in a GMP manufacturing environment
minimum 4 years of hands-on experience in fermentation, purification or pharmaceutical manufacturing process
minimum 4 years of managerial experience guiding teams in a GMP environment
proven knowledge of cGMP requirements to ensure compliance
experienced in handling major/critical deviations and leading complex investigations
strong focus on quality and attention to detail
effective task/time management organizational skills
capacity to develop solutions to technical issues of moderate scope
ability to organize, analyze/interpret, and effectively communicate data and results
motivated, self-starter with strong mechanical aptitude
good interpersonal, team, and communication skills
strong proficiency in Microsoft Word, Excel, PowerPoint
familiar with other enterprise systems such as DeltaV, MES, and SAP
strong leadership, organizational, communication, technical and writing skills
experienced in presenting to internal and external stakeholders, auditors or inspectors.

Senior Manager, Manufacturing Compliance

Key skills