Routine management & coordination of GMP compliance systems and policies for Alewife facility. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Review of production records for compliance. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and HGT goals. Responsible for adhering to
GMP regulations, cGMP’s, company policies, and DNA leadership capabilities.
- Must be able to work occasional Weekends.
Quality System management and improvement
Education and Experience Requirements
A minimum of a B.S. degree in science or engineering with at least 3 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Other Job Requirements
Must be flexible to work late shifts and weekends on ad-hoc basis.
Key DNA Leadership Capabilities:
proficiency/excellence in all Job Scope 2 capabilities
Accountability & Ownership
Judgment and Decision Making
Energy and Drive