Job Details

Manager, Quality Assurance

Reporting directly to the Director of Quality, the Manager of Manufacturing Quality Assurance (MQA) is responsible for the quality oversight of Manufacturing Operations within the Greenville Solutions Facility.

Key Activities:

• Ensure that a robust product disposition process is executed for all product that is available for distribution.
• Work with Operations and the MRB (as appropriate) to ensure sound and timely decisions are made regarding product impact, product release and overall risk analysis.
• Ensure that all customer complaints are thoroughly investigated, where applicable.
• Ensure detailed, thorough investigations are completed to current industry expectations and in a timely manner within the site's Manufacturing Operation.
• Ensure that the department maintains compliance with associated regulations from the site standards list and industry best practices, while conducting gap assessments.
• Ensure that the risk management program remains current with regulatory, global, and local requirements and assessments.
• Interface with outside regulatory and legal authorities as appropriate.
• Will provide leadership to Greenville Operations on cGMP and other compliance requirements.
• Oversee the performance of department staff. Establish, manage and monitor departmental budget and spending against stated variances.
• Establish, communicate and execute against strategic quality and site objectives.
• Identify, evaluate, select and implement against continuous improvement and compliance initiatives.

Qualifications:

• Minimum of a B.S. degree, scientific or engineering degree.
• Certifications preferred: CQA, CQE, CQM.
• 10+ years of experience managing quality systems or directly associated with manufacturing or manufacturing quality in a sterile dosage pharmaceutical or medical device facility. (i.e., 21CFR211, 21CFR820, ISO 9001, ISO 13485).
• Experience in leading, conducting and writing investigations.

This position may be available in the following location(s): US - Greenville, SC (Plant)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.