Manager, Quality Assurance

Position Overview

Under direction from the VP of QA/RA, lead management of the quality system to ensure it meets applicable regulatory requirements. Through administration of Quality Assurance, process improvement initiatives and product design verification activities and distribution to ensure that products sold meet the needs and expectations of customers.

What You'll Do

• Establish strategies to maintain compliance with Regulators such FDA, DEA, NAP, and Board of Pharmacies. Coordinate different functions to proactively identify, manage, and mitigate compliance risks across the entire product lifecycle.
• Maintain a strong quality management system, implement regular audits, provide ongoing employee training, and ensure ongoing compliance with changing regulatory requirements.
• Provide direct and strategic surveillance of the Quality Assurance team for the manufacturing and distribution of medical devices and pharmaceuticals.
• Ensure effectiveness of the QMS by staying updated on evolving regulations, guidelines, and trends that may impact the company.
• Lead and manage a QA team by building, mentoring, and developing quality professionals.
• Provide leadership and technical expertise to the QA team and other departments on quality-related matters.
• Work with other departments, such as sales, engineering, manufacturing, and regulatory affairs, to ensure quality throughout the product lifecycle.
• Foster a culture of quality throughout the organization through training, communication, and leadership.
• Address raising events that require decision making, collaboration, and communication with different levels of the organization.
• 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 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.
• Oversee onsite laboratory, documentation system and associated requirements.

Qualifications: What You'll Bring

• Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 5 years in a Management or Supervisor role in the medical devices and pharmaceutical industries.
• Prior experience participating and/or leading FDA audits.
• A proactive, hands-on approach with the ability to take ownership and drive results.
• In depth knowledge of 21 CFR 210, 211, and 820.
• Strong knowledge of relevant regulatory guidance, including pharmaceutical current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO.
• Understanding of flow control, contamination control, industrial microbiology.
• 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.
• 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.
• Strong problem solving skills.