Validation Manager

3 weeks ago


Durham, North Carolina, United States Beam Therapeutics Inc. Full time
Job Summary:

The Validation Manager will be responsible for leading the Commissioning, Qualification, and Validation (CQV) program at Beam Therapeutics Inc. This role will oversee the development, implementation, and maintenance of CQV processes and procedures to ensure compliance with global regulatory requirements.

Key Responsibilities:

Develop and implement CQV strategies and plans to support Beam's global GMP operations
Lead CQV/CSV on various technology development and implementation projects
Create, execute, and close-out validation activities and deliverables
Maintain the validation program, including policies, SOPs, and plans
Collaborate with GMP functions onsite and globally to provide continuous improvement of the validation program

Requirements:

Bachelor's or Advanced degree in a scientific discipline
5-8 years of experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development, and/or quality
3-5 years of project management experience, including support of large capital projects
Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions
Solid knowledge of global regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspections is preferred
Experience with lifecycle management software, experience with Kneat preferred
Strong team player with a customer service approach and solution-oriented mindset
Ability to work onsite daily and willing to have a flexible schedule during peak times

What We Offer:

Beam Therapeutics Inc. is committed to establishing the leading, fully integrated platform for precision genetic medicines. We offer a dynamic and collaborative work environment, competitive compensation and benefits package, and opportunities for professional growth and development.

Join our team of talented professionals who are passionate about making a difference in the lives of patients suffering from serious diseases. Apply now to become a part of our team and contribute to our mission of providing life-long cures to patients in need.
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