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Actalent CLINCIAL- Senior Compliance Manager - Not Remote in Bedford, Massachusetts

On Site Clinical Compliance Manger

JOB DESCRIPTION

• 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.

MUST HAVE:

  • 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

Experience Level:

Expert Level

About Actalent:

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.

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