Quality Manager

Job Description

Responsibilities:

•Develop, implement, and monitor aspects of site Quality Management System, including, but not limited to:

*site Internal Auditing program

*site CAPA program

*site Document Control program

*site Change Control program

*site Deviation Management program

*site Continuous Improvement program

*Conduct trending of quality events

•Communicate product issues and deviations to clients, when required

•Ensure a high level of internal and external customer service by responding to customer needs in a timely manner

• Respond to CAPAs (site, supplier quality, safety, audits, etc) as assigned

•Revise or create standard operating procedures

•Establish quality standards, objectives, and goals and communicate to site personnel

•Participate in and provide information for regular Quality Management Review Meeting discussions

•Approval of specifications, sampling instructions, and test methods

•Promote quality achievement and performance improvement across the organization

•Respond to or coordinate response to any out of specification reports related to site product

•Ensure compliance with all applicable regulations and requirements

•Write, review, and/or approve site validation protocols and summary reports

• Perform internal and supplier audits as required

•Prepare reports and data related to departmental objectives or requirements (such as APR)

•Oversee hourly quality personnel (scheduling, performance reviews, disciplinary action, hiring & firing)

Skills:

•Self-starter

• Positive attitude

•Able to work in fast-paced environment

•Ability to generate and comprehend technical/analytical reports

• In-depth knowledge of the regulatory environment for manufacture of OTC/FS.

•Capable to manage tasks in matrix and ability to interact successfully with multi-functions globally and regionally

• Strong analytical, problem solving, and decision-making skills

•Excellent verbal and written communication skills

•Success working with multifunctional, regional and global teams

• Excellent communication/negotiation skills required

• Extensive working knowledge of applicable quality and regulatory standards and regulations

•Experience in risk management, validation, analytics and microbiology, within a GMP environment

Requirements:

•Must be certified in food safety (SQF, HACCP, or equivalent)

•Domestic travel (<10%)

•Experience managing others

• Able to sit/stand for periods lasting 2 hours or more

•Able to work in unconditioned environments {both hot and cold)

•Must be able to wear company issued protective equipment

Qualifications:

Education: Associate degree, plus 5 years of quality experience, including supervisory experience; or BS degree.

Experience: Minimum of At least 4 years working in a regulated environment Minimum of 2 years of supervisory experience