Sr. Quality Manager



Advert ID




Job Type




Salary Range

Up to USD0.00 per year

No. of Openings


Branch Information

Southern California Engineering - (USA) 2100 Main Street 4th Floor CA Irvine , CA 92614 Phone : 949-862-6150



Job Description

Senior QA Manager

The Senior QA Manager will assume the responsibility for Quality oversight. This individual is the primary QA point of contact for new product introductions, non-conformance investigations, process/facility changes, and corrective actions for one or more areas of operation. This individual will play an integral role within a cross-functional leadership team that includes Manufacturing, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

· Document Control

· Change Control

· Investigations, Deviations; Out of Specification

· SOP Revisions

· Risk Management

· CAPA (Corrective Actions / Preventative Actions)

· Operating and Manufacturing Procedures

· Audit liaison and commitment tracking / closure

· Project team participation and leadership

· Product disposition

· Equipment and System Validation

Additional responsibilities include management and evaluation of compliance issues/regulations, assure progress against commitments to regulatory agencies, identify compliance gaps and lead focused teams to resolve compliance issues, provide written compliance assessments to management on request, and interpret regulations and apply them to a multi-product, multi-modality environment.

Preferred Qualifications

· Degree in Biology, Chemistry

· 3-5 years' experience in the Pharmaceutic industry

· Experience with cGMP Production environments and an understanding of its regulatory requirements

· Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development.

· Experience participating in, managing, and responding to corporate audits/regulatory inspections.

· Excellent written and verbal communication skills.

· Analysis of complex problems and delivery of clear and timely feedback

Strong interpersonal skills