Job Title
Senior Quality Assurance Manager
Requisition
JR000014325 Senior Quality Assurance Manager (Open)
Location
Madison, WI
Additional Locations
Job Description Summary
Job Description
The Senior Quality Assurance Manager leads site Quality Assurance, working closely with the Director of Quality to ensure compliance. Acting as a key link between cross-functional groups such as regulatory affairs, maintenance/metrology, materials management, quality control, and manufacturing, this role drives improvements and compliance efforts. The manager cultivates a culture of quality, compliance, safety, and service, oversees Quality Analysts and Engineers, and mentors team members. Operating independently, the Senior Quality Assurance Manager provides clear direction and support for projects, production, and compliance activities.
Essential Functions
Manage the implementation and maintenance of quality assurance systems and activities, ensuring compliance to site and corporate policies, applicable regulations and providing strategic and technical input for standard and best practices for regulatory compliance.
Oversee CAPA processes and Management Review presentations; manage and approve CAPA, complaint, investigation, audit, Change Control, and deviation records; write, revise, review, and approve standard operating procedures and work instructions.
Lead the site supplier quality management processes, including participation in supplier selection, auditing, assessment, and investigation/corrective actions.
Ensure personnel and work environment operate safely, ensuring EHS practices are followed.
Develop, coach, and mentor site personnel to enhance organizational growth and quality culture; develop and maintain site audit programs (regulatory, external, and internal).
Manage Quality Assurance personnel to support engineering, manufacturing, and quality operations; oversee document and record management for compliance; and lead the site Quality Engineering function for effective issue investigation and corrective actions.
Support management of or manage quality system training program, ensuring comprehension and compliance of procedures throughout cross functional areas at the site.
Use critical thinking skills to bring solutions to quality and technical topics such as investigations, root cause analysis, and risk management tools.
Develop and generate quality system metrics for tracking and trending purposes and recommend actions as appropriate.
Make data driven and highly technical decisions that support compliance and site quality policy.
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 and independently lead critical compliance activities.
May perform additional duties as required and assigned by management, including duties that support overall company initiatives.
Minimum Requirements
Bachelor's degree in a scientific discipline or equivalent.
8 years of experience in a cGMP environment within the pharmaceutical and medical device industries.
5 years in a Quality Assurance role, with expertise in product quality from clinical supply to commercial manufacturing, including cross-functional process implementation.
3 years of supervisory experience leading a quality team.
Proficient in cGMPs and regulations, with experience in hosting or facilitating regulatory inspections.
Strong knowledge of ISO 9001, ISO 13485, and MDSAP regulations.
Excellent interpersonal, communication, organization, and project management skills, including experience in presenting topics and training personnel.
Strong critical thinking, problem-solving, and decision-making abilities.
Qualified auditor through certification or experience.
Ability to analyze and trend data.
Preferred:
Organizational Relationship/Scope:
The Quality Assurance Manager collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, Maintenance/Metrology, Engineering, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Director, Quality.
Working Conditions:
The Quality Assurance Manager will mainly work in an office environment but may also be required to work in manufacturing and warehousing areas. Travel required is 5-10%.
It is the expectation this position works during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.
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