Senior Quality Manager Job

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Sr. Quality Manager
Job Summary
Quality Manager is responsible for the day-to-day operations of the Quality function for leading the development, maintenance and execution of the business's Quality Management System in support of production activities to comply with ISO 9001. This role will have up to 10% travel for such things as supplier audits and support, as needed. The position provides the benchmark for world-class quality practices while working closely with Production to maximize production efficiency and provide training to prevent NCMRs and CAPAs.
Essential Job Function
Identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes.
Optimizes processes to comply with existing and new regulatory requirements.
Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions.
Oversee Quality System elements including among others Changes, Deviations, CAPA, NCMR, Validation/Verification of Equipment and Processes with staff.
Support management of customer feedback channels with QA staff and Production staff.
Oversee Problem Solving activities with Operations staff when necessary.
Coordinate efforts for projects and Continuous Improvement.
Coach and mentor staff where and when support is needed.
This role represents our QMS Management rep and represents management of the site during site specific audits, customer visits, inspections, inquiries, customer feedback.
Oversee Quality Management Systems inclusive of Corrective and Preventive Action (CAPA), Document Control, Internal/Customer auditing, Engineering Change Order (ECO), Data Analysis, Verification and Validation activities and Customer Complaint Systems. Brainstorms improvements to the Quality Management System and rewrites procedures as necessary for maximum efficiency.
Gather and present data on the effectiveness of the Quality Management System for management review.
Supervises Quality managers/staff including annual performance reviews, compensation and resource allocation to ensure deliverable timelines are met.
Confers with Project Management and Production Team to provide quality advice and to resolve problems.
Identify roadblocks and recommend and implement process improvements for QA and QC Team for highest efficiency.
Designs and delivers regular training to Quality and Production teams and oversees the training tracking system.
Leads risk assessment and management of new products and processes. Proposes solutions to maximize success at Production, including quality and efficiency.
Coordinates and supports on-site audits conducted by regulatory agencies and/or customers.
Performs external supplier audits to ensure ISO 9001 compliance.
Responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations.
Additional responsibilities may be assigned as needed.
Minimum Requirements
Bachelor's degree from a four-year college or university preferably in a life science discipline or equivalent experience.
Quality position in a Life Science business, managing product or service in a regulated QMS. At least 5 years of experience in an ISO (preferably 9001) and/or FDA regulated environment, with at least 5 years of direct quality relevant experience.
Experience with ISO 9001 certification required.
Experience in a Good Manufacturing Practice (GMP) environment.
Ability to make and implement policy and procedure effectively through timely training.
Strong ability to write clear, concise communication to customers and suppliers.
Ability to collaborate with site leadership team to create consensus on initiatives.
Superior team building and leadership skills.
If you are interested, please apply or confidentially send your resume to ****.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (**MEMBERS ONLY**SIGN UP NOW***.) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

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