Conformance & GMP Projects Specialist: Local Candidates only- Hybrid role on site 2 times per week. Position Summary Focus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions. Position Duties & Responsibilities Deviation Management * Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence. * Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement * Influences direction of investigations and communicates with all levels of employees * Write concise, accurate and effective deviation reports for investigations that meet compliance expectations Change Management * Coordinate and manage change applications (Local and Global). * Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures. * Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters. * Support process development/improvement projects, site-wide and global projects. Requirements/Preferences Education Requirement(s): * Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc. * Minimum Experience BS 6+ years * MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience Skill & Competency Requirements: (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.) MUST have experience/expertise in cell and gene therapy manufacturing * Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc. * Experience with regulatory and cGMP requirements for pharmaceutical manufacturing * Strong analytical skills to identify root causes and prepare balanced decisions * Ability to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals. * Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences. Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.) * SAP, ValGenesis * Deviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X) * Risk Assessments * Authoring/Reviewing Documents for Regulatory Review * Lean Six Sigma and Continuous Improvement Methodology * Project Management Professional (PMP) Travel Requirements: (if applicable)
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.