Quality Manager- Manufacturing

Welcome to CIBA Vision - the company that considers its employees to be its greatest asset.

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How do you spend your day? Are you passionate about what you do? At CIBA Vision, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
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With worldwide headquarters in Atlanta, CIBA Vision is a global leader in the research, development and manufacturing of optical and ophthalmic products and services, including contact lenses and lens care products. CIBA Vision products are available in more than 70 countries worldwide.
Reporting to the Quality Head - Atlanta, the Quality Manager primarily provides quality assurance support for the SMU involving compliance to FDA, cGMP, ISO standards and CIBA Vision SOP's. Serves as a technical and regulatory consultant to operations management. Develops, maintains and improves quality systems which assures lens production meets established specifications and are in compliance with various regulatory standards. Establishes and directs department quality programs and initiatives that drive continuous improvement. The Team Leaders of Quality Assurance / Records Review, Quality Support, Compliance and Microbiology directly report to this position.

Know, understand, and comply with all Health, Safety, and Environment (HSE) guidelines. Report unsafe conditions, injuries, illnesses, and hazardous materials releases. Wear necessary protective equipment. Attend and complete required HSE training programs. Comply with company guidelines and procedures.

Qualifications
Minimum Required:
BS/BA in Physical/Life Sciences and/or Engineering.
6-9 years overall related experience, to include:
5 years manufacturing experience
5 years quality or regulatory experience
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Strong knowledge of cGMPs / Regulatory / Validation requirements.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Knowledge of validation in a medical devices/pharmaceutical environment including experience with cGMP, 21 CFR Part 11.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Knowledge of Change Control, Statistical Process Control, Training Systems, and Manufacturing Processes is required.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Experience with ISO standards in Medical Devices.
3 years management experience
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Process Improvement, SPC, Quality Assurance, Statistics, Mathematics, or Quality Engineer
Word and Excel Software Package.
Proven Process Improvement, SPC, Quality Assurance experience.

Preferred Level:
MS/MA Physical/Life Sciences and/or Engineering.
6-9 years overall related experience, to include:
7 + years manufacturing experience
7 + years quality or regulatory experience.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Strong knowledge of cGMPs / Regulatory / Validation requirements.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Knowledge of validation in a medical devices/pharmaceutical environment including experience with cGMP, 21 CFR Part 11.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Knowledge of Change Control, Statistical Process Control, Training Systems, and Manufacturing Processes is required.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Experience with ISO standards in Medical Devices.
5 + years management experience
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Process Improvement, SPC, Quality Assurance, Six Sigma
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Statistics, Mathematics, or Quality Engineer
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Engineering or Process Validation Experience
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Process Improvement, SPC, DOE, Quality Management, ISO and GMP Audits
Word, Excel, Access, Powerpoint, MiniTab
Proven Communication and Organization experience
Proven Leadership experience
Electronic Batch Record, MES/SAP
Microbiology / Sterility


Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.

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