The Manager of Quality Assurance will be responsible for managing the implementation and execution of the Catalyst’s Quality System under the oversight of the Executive Director of Quality. The candidate will be the primary Quality contact for all Quality Management System related matters and will have strong experience in GxPs, relevant FDA, Canada, EU, and Japan regulations as well as the ability to function independently in a dynamic, fast-paced environment.
Applicants should have a BS/MS in a scientific or health-related filed, with a minimum of 10 years of Quality Assurance / Compliance experience in the pharmaceutical / biotech industry.
The Manager of Quality Assurance will work to ensure the roll out and on-going compliance of the Catalyst Quality System and associated systems, procedures, and standards. Duties
· Assist in the management and execution of the Catalyst Quality Audit Program, by performing Quality Assurance activities including audits, investigations, CAPAs, change control, validation, etc.
· Assist in the management and execution of Regulatory Authority Inspections, Business/Licensing Partner audits, and other audit/inspection activities, as directed.
· Implement and manage the Catalyst Product Complaint Program.
· Implement, manage and maintain a GxP compliant electronic Quality Management System (QMS) document control system by facilitating related tasks including, but not limited to:
o Standard operating procedure development, maintenance, and storage/retention
o Training development, maintenance, and storage/retention
o Business Continuity and Disaster Recovery
o Change Control
o Product Complaints
o Product Recall
· Provide GxP subject matter expertise (SME) to internal and external stakeholders.
· Lead and manage stakeholder training on the eQMS document control system.
· Ability to interact effectively with internal and external stakeholders.
· Other duties, as assigned.
· Advanced understanding of pharmaceutical development, from pre-clinical to late stage and commercialization.
· Thorough knowledge of FDA and EU regulations and ICH Guidelines.
· Although this position would not have direct oversight of pharmacovigilance (PV) activities, it would be responsible for ensuring that post market surveillance requirements are met by monitoring PV’s compliance via internal and vendor audits.
· Strong leadership ability.
· Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
· Exceptional communication and interpersonal skills
· Ability to analyze complex situations / issues and effectively communicate situations / issues to stakeholders.
· Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
· Ability to multi-task and prioritize work.
· Strong organizational ability.
· Demonstrable computer skills.
· BS/MS in a scientific or health-related filed, with a minimum of 10 years of Quality Assurance / Compliance experience in the pharmaceutical / biotech industry.
· Professional certifications, such as Six sigma, ASQ, CQA, SQA, etc., a plus.