Quality Manager

Job Description Summary

The Quality Manager is responsible for providing Quality leadership and support to the site. This role works closely with the Director, Quality to maintain a proactive approach to system and functional area compliance requirements. The role is a critical link between cross functional groups that include regulatory affairs, engineering, materials management, quality control, and manufacturing. This position manages quality assurance and quality control roles at the site and acts as a mentor to team members.

Key Responsibilities

• Ensure personnel and work environment operate safely, ensuring EHS practices are followed.
• Develop, coach, and mentor site personnel to improve bench strength and build on the quality culture.
• Manage the implementation and maintenance of quality assurance systems and activities, ensuring compliance to site and corporate policies and applicable regulations.
• Oversee the site CAPA processes and Management Review presentations.
• Lead the site supplier quality management processes, including supplier selection, auditing, assessment, and investigation/corrective actions.
• Manage Quality Assurance and Quality Control personnel to ensure engineering, manufacturing operations and quality are fully supported.
• Manage the generation, review, and archival of documents and records used to support current Good Manufacturing Practice.
• Lead management of and approve CAPA, complaint, investigation, audit, Change Control, and deviation systems records.
• Manage the site Quality Engineering function to facilitate issue investigation, root cause determination, and proposed corrective actions.
• Support management of or manage quality system training program.
• Use critical thinking skills to bring solutions to quality and technical topics such as investigations, root cause analysis, and risk management tools.
• Write, revise, review and approve standard operating procedures and work instructions.
• Develop and generate quality system metrics for tracking and trending purposes.
• Develop and maintain site audit programs (regulatory, external, and internal).
• Provide/review/approve information to support regulatory filings, including responses to inquiries, review of CMC, labeling review, etc.
• Participate as a leader in regulatory inspections.
• Independently lead critical compliance activities.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent, or Bachelor's degree and a minimum of 8 years of experience in a cGMP environment (pharmaceuticals and medical device industries).
• At least 4 years in a Quality Assurance function within a cGMP environment with demonstrated experience in product Quality from clinical supply to commercial manufacturing.
• At least 5 years of supervisory/people leadership experience.
• Excellent interpersonal, communication and presentation skills.
• Excellent organization and project management skills.
• Strong critical thinking, problem solving and decision-making skills, with ability to trend data.
• Working knowledge of cGMPs and regulations including experience hosting or facilitating regulatory inspections.
• Experience with Design Quality Validation and Verification is preferable.
• Ability to travel (5-10%).
• Robust understanding of ISO9001, ISO13485, MDSAP regulations.

Working Conditions

The Quality Manager will mainly work in an office environment onsite at a manufacturing facility but may also be required to work in manufacturing and warehousing areas. This position works onsite at a manufacturing facility during normal business hours M-F, but work may be performed outside normal business hours when required.