Compliance Program Manager
Industry: Medical Device
The Compliance Program Manager will build a compliance program and drive strategy for software, instrument, reagent, and service offerings for regulated customers. They will be responsible for identification of new regulatory GLP trends and work closely with the service and product management teams to develop and implement new offerings for our regulated customers.
The Compliance Program Manager will provide expert feedback on regulated customer workflow and compliance needs from a customer perspective and support worldwide sales and service through key account management and product or service training.
- Build a compliance program and drive strategy for software, instruments, reagents, and service offerings for our regulated customers.
- Monitor market developments for compliance product portfolio, including competitive landscape and regulatory developments. Evaluate performance of current products and competitor products, independently analyze and interpret data, and provide feedback (from the customer perspective) to marketing and product development.
- Work with Product Managers and the Service organization to develop marketing strategies and collect regulated customer feedback (VOC) to create and implement new product or service offerings for regulated customers.
- Partner with FDA and other regulatory agencies to stay apprised of compliance and regulatory developments and collect feedback on our products and services.
- Deliver training and support to global sales team and other business units within Molecular Devices.
- Support pharmaceutical and regulated customer key accounts and participate in customer audits.
- Perform mock inspections to determine product, service, and system compliance with FDA or other regulatory requirements and readiness for inspection.
- Bachelor’s degree in life science disciplines strongly preferred. Lab experience is a plus.
- Minimum of 5 years’ relevant GMP/GLP experience in quality systems in the pharmaceuticals industry.
- Demonstrated understanding of current international regulations, processes and issues in drug/biologics development. Includes sound knowledge of GMP, GLP, FDA, EMEA, Ph. Eur., USP, CFDA and other relevant guidelines with the ability to assess compliance risks.
- Experience in GMP/GLP auditing.
- GMP/GLP certification a plus.
- Strong knowledge of computer system validation, GAMP, data integrity and compliance to FDA 21 CFR Part 11.
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy.