Principal Compliance Specialist

Principal Compliance Specialist

Title: Principal Compliance Specialist
Location: United States-Massachusetts-Allston
Other Locations:

Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.


The Principal Compliance Specialist is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.
The Quality Systems department manages Change Control, Document Control, CAPA, Product Quality Reviews, Quality Engineering and Continuous Improvement activities.

Quality Engineering supports the function of Manufacturing, Facilities, Engineering and Validation.
Primary responsibilities are focused on the Quality Systems that allow for execution of projects, preventative and corrective maintenance for all equipment, facilities and utilities at the Allston Landing Facility.

Responsibilities include:
· Providing Quality Review and of deviations related to Equipment, Utility, Facility, Validation and Metrology
· Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution
· Reporting metrics in support of Deviation/CAPA/Effectiveness reviews performed by the department.
· Interpreting complex, explicit documentation to ensure quality standards and compliance

Provides training to new employees

Basic Qualifications:

· Bachelor's Degree with 5-8 years of experience or equivalent or Master's degree with 1-3 years of experience. Degree(s) in Engineering or Life Sciences preferred.
· Experience executing technical CGMP documents.
· Strong written and verbal communication.
Proficient in Microsoft Office applications.

Preferred Qualifications:

· Experience working in Quality in a GMP environment.
· Experience working in a Quality role supporting production equipment.
· Experience with technical writing.

Ability to operate in an environment with strict timelines.