Sr. Manager, QC-Microbiology And Viral Safety

Employer
Actalent
Location
Boston, Massachusetts, US
Salary
Competitive
Posted
Jul 15, 2021
Closes
Jul 28, 2021
Ref
2317424473
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Description:
This role is accountable for developing, implementing and managing the microbial contamination control and viral safety programs at the manufacturing plant located in Marlborough, MA. This is an exciting opportunity to contribute to the buildout and qualification of a new manufacturing facility for viral vectors and vaccines, establishing a robust and comprehensive environmental monitoring program and managing the microbiology and viral safety testing of materials, intermediates and drug products. The Sr. Manager, Quality Control - Microbiology & Viral Safety reports to the Site Quality Head. The position will be located in Marlborough, MA. Job Responsibilities Accountable for the development and life cycle management of the Environmental Monitoring (EM) program, including but not limited to facility and utilities environmental performance qualification, routine monitoring, data trending, EM excursion investigations Develops user requirements and contributes to the selection and implementation of the electronic tools for managing the EM program and laboratory notebooks Responsible for the development and lifecycle management of site specific standard operating procedures related to microbial contamination controls and viral safety Establishes requirements and develops on-the-job-training plans for the QC Microbiology & Viral Safety team. Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures. Acts as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological and viral safety testing. Ensures compliance of selected QC laboratory equipment to Part 11 and Data integrity regulations and guidelines. Schedules, reviews data and oversees microbiological and viral safety testing of materials, intermediates and drug products. Ensures timely completion of testing deliverables in accordance to commitments made to Clients and corresponding Quality Agreements. Provides input and manages execution of method validation and verification for microbiological and viral safety testing conducted at the site Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goals
Skills:
edms, documentation control, documentation writing, Quality assurance, veeva, trackwise, electronic document management system edms, Gmp
Top Skills Details:
edms,documentation control,documentation writing,Quality assurance,veeva,trackwise,electronic document management system edms,Gmp
Additional Skills & Qualifications:
Qualifications: Comprehensive knowledge of global GMP regulatory requirements for biologics, cell and gene therapy products Experience with managing EM programs and drug product microbiological testing is required Experience with aseptic processing operations is preferred Experience with environmental monitoring performance qualification is required Excellent oral and written communication skills Demonstrated ability to lead investigations, solve problems, synthesize data, summarize outcomes and provide recommendations on a compliant path forward Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
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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