We are searching for an experienced Senior Compliance Manager to support a global pharmaceutical company! 10+ years of experience within pharmaceutical manufacturing or FDA regulated environment required!
• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements
• Supervise the QA Documentation department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records
• Manage electronic document processing, retrieval, and distribution systems (EDMS), electronic learning management system (LMS), electronic Quality Management System (TrackWise), etc.
• Administer document and system access rights and revision control to ensure security of system and integrity of master documents
• Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
• Supervise the creation of an annual training calendar and other training initiatives at the site
• Provide expertise and input to other functional areas affecting controlled documents and records
• Assist with FDA and other compliance audits including corporate audits.
• Facilitate and follow up with stakeholders with regard to responses to audit observations
• Prepare annual internal audit schedule and perform execution of same
• Oversee site vendor management program including performing annual vendor risk assessment
• Oversee harmonization efforts between corporate and plant Quality procedures and policies
• Provide QA review of Annual Product Reviews (APRs) to identify trends and recommend CAPA as needed
• Provide QA review of quality events such as unplanned/planned deviations and change controls
• Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA
• Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS
initiatives, and related projects
• Participate in Regional Quality related projects and initiatives, acting as an ambassador between corporate and plant
• Issuance of Quality Alerts, FAR/Recall as per internal procedures
qms, quality management system, trackwise, root cause analysis, capa, edms, product compliance, complaint handling
Top Skills Details:
qms,quality management system,trackwise,root cause analysis,capa,edms
Additional Skills & Qualifications:
• BS in chemistry or related scientific field
• Minimum ten (10) years of related experience in pharmaceutical (manufacturing) environment, biotech industry, Quality Assurance, Quality Control and/or production, or FDA regulated industry.
• Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
• Superior internal and external customer service/people skills
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.