Manager II, Quality Compliance

Job description

About the Role: This position is responsible for supporting the Product Quality Complaint program and ensuring that all complaints are handled in accordance with GMPs and health authority requirements and expectations. This position will also be responsible for supporting Annual Product Reviews. In addition, the role includes supporting other QMS areas, when needed (i.e. Audits and inspections, Change Control, Document Control, CAPA). Let’s talk about some of the key responsibilities of the role: - Support of the product complaint program, from intake to closure, including: - Open Product Complaint Investigations - Liaise with Call Center staff for Product Complaint Intake - Follow-up directly with complainants, when necessary - Participate in Weekly Product Complaint Meetings - Prepare Response Letters to Complainants - Review proposed Product Complaint investigations and close the Complaints - Contribute Product Complaint Data to Annual Product Reviews - Prepare monthly complaint metrics and Management Review Presentations - Support Regulatory Inspections or Alliance Partner Audits, as required - Author/Revise or Approve Controlled Documents - Understand the regulatory environmen...