Location:
Minnetonka, MN
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Pay range:$68.00 - $78.00 per hour
An experienced QMS Senior Manager
is sought to lead quality management system initiatives, ensuring top-tier product quality and regulatory compliance. This role involves overseeing quality processes including audits, harmonization of quality systems, product release, and equipment administration, in line with regulatory standards (21 CFR Parts 210, 211, 820, 11, ISO 13485, and ICH Guidelines).
Key Responsibilities:
- Administer and monitor quality processes; track performance and identify improvements.
- Support investigations through data collection and analysis.
- Manage GMP production batch records and ensure GXP compliance.
- Compile product release documentation and issue shipment authorizations.
- Schedule equipment calibration and support qualification activities.
- Collaborate cross-functionally to maintain product quality and compliance.
- Conduct training, facilitate audits, and support regulatory inspections.
- Lead quality systems including CAPA, Deviation Management, and Supplier Quality.
- Drive continuous improvement and screen document changes.
- Oversee preventative actions aligned with 21 CFR Part 820 and ISO13485.
- Support internal/external audits and manage field actions.
- Assist in reviewing and investigating customer complaints and MDR assessments.
- Utilize electronic QMS systems to manage manufacturing and quality events.
- Lead and mentor the quality system team.
Qualifications:
- BS/BA in a scientific or technical field (e.g., Engineering).
- Minimum 8 years in the life sciences industry; 5+ years of supervisory experience.
- Strong knowledge of GXP, 21 CFR, EU GMP, ICH, ISO, and QSR regulations.
- Proven leadership in quality systems within manufacturing/operations environments.
- Experience with drug-device combinations, medical devices, or aseptic products preferred.
- Excellent communication, problem-solving, and technical training skills.
- Ability to work effectively with internal and external stakeholders.
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