CHARACTERISTICS OF THE CLASS: Under direction from the VP of QA/RA, manage the quality system to ensure it meets applicable regulatory requirements. Through administration of Quality Assurance & Control activities, process improvement initiatives and product design verification activities, assures that products sold meet the needs and expectations of customers. Perform related duties as required.

ESSENTIAL DUTIES:

• Direct management of the Quality Assurance team.

• Serve as the site’s Management Representative during agency investigations, audits, and inspections and prepares required responses and corrective action reports. Manage the internal audit programs and coordinates external audits and inspections from government agencies, including closing observations.

• Initiate and implement quality improvement activities as appropriate to raise the quality and compliance of the site’s product line and processes, which includes educating and training employees on the Quality Management System.

• Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions. Conduct Management Review in compliance to ISO and FDA requirements.

• Manage and maintains compliance with FDA Quality System Requirements. Assist regulatory Affairs and Operations with product development, regulatory submissions and technical information for international registrations.

• Support the market-release of products as necessary, including review of labeling, promotional materials, product/manufacturing process changes and related Quality System documentation changes.

• Manage sterilization program and coordinate related activities with contract sterilizer and 3rd party validation of processes.

• Manage the Customer Complaint program and ensure investigations and corrective actions are timely and effectively implemented.

• Serve as the Coordinator of the quality control resources for problem identification, resolution, loss reporting and continuous improvements.

• Support engineering efforts by participating in product development projects, representing quality assurance and the customer.

• Design, implement and document procedures for process control, process improvement, testing and inspection. Perform root-cause analysis and other problem solving activities to identify and implement effective corrective actions and process improvements.

• Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

RELATED DUTIES:

• Prepares all reports for management as requested.

MINIMUM QUALIFICATIONS:

Training and Experience.

• Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 2 years in leadership role in a chemical manufacturing environment with demonstrated pattern of success.

• Prior experience participating and/or leading FDA audits.

Knowledge, Abilities and Skills

• In depth knowledge of 21 CFR 210, 211, and 820.

• Specific knowledge of non-sterile OTC or Rx liquids.

• Understanding of classified manufacturing areas (i.e., Class 10,000 per Fed STD 209E or ISO Class 7).

• Understanding of flow control, contamination control, industrial microbiology.

• Thorough knowledge of Good Manufacturing Practices.

• Strong knowledge of relevant regulatory guidance, including pharmaceutical current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO.

• Strong knowledge of Lean Manufacturing disciplines and continuous improvements.

• Ability to supervise a staff of quality employees.

• Ability to communicate effectively, both verbally and in writing.

• 15736447. to read and understand published regulations.

• Ability to work effectively cross-functionally, influencing other key individuals outside of direct chain of command.

• Excellent analytical and interpersonal skills.

• Strong skills in applying statistical methodologies and problem-solving techniques.

• Skill in writing and editing technical documentation.

• Strong problem solving skills.

PHYSICAL REQUIREMENTS:

Must be able to stand for long periods of time occasionally.

Working Conditions

Office and manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.