Senior Quality Assurance Manager

3 weeks ago


Michigan, United States Meet Full time
About Meet

Meet is a pioneering biotech company dedicated to developing cutting-edge therapies. We are seeking a dynamic and hands-on Senior Quality Assurance Manager to lead and manage our QA activities.

Key Responsibilities
  • Develop and Implement a Quality Management System

Develop, implement, and maintain an effective Quality Management System that aligns with regulatory standards (FDA, EMA, ICH, etc.).

  • Ensure Compliance with Regulatory Requirements

Ensure that all processes comply with GxP requirements (GMP, GCP, GLP).

  • Manage SOPs and Regulatory Compliance

Oversee the management of SOPs, ensuring they are current, effective, and properly implemented.

  • Lead Regulatory Inspections and Audits

Lead preparation and management of regulatory inspections and audits.

  • Provide QA Oversight

Provide QA oversight for all clinical trials, including the review and approval of study protocols, clinical trial agreements, and informed consent documents.

  • Monitor and Audit Clinical Trial Sites

Monitor and audit clinical trial sites, CROs, and other vendors to ensure compliance with study protocols and regulatory requirements.

  • Investigate and Resolve Quality Issues

Investigate and resolve any quality issues or deviations in clinical trials.

  • Collaborate with Cross-Functional Teams

Collaborate closely with R&D, manufacturing, and clinical teams to ensure quality is integrated into the development process.

  • Provide QA Support for CMC Activities

Provide QA support for CMC (Chemistry, Manufacturing, and Controls) activities, including batch record review and release, stability testing, and validation.

  • Lead and Mentor a QA Team

Lead and mentor a small QA team, fostering a culture of quality and continuous improvement.

  • Manage Day-to-Day QA Activities

Hands-on management of day-to-day QA activities, including document control, internal audits, and quality issue investigations.

  • Develop and Implement Training Programs

Develop and implement training programs to ensure all staff are aware of and comply with quality standards.

  • Identify and Implement Process Improvements

Identify and implement opportunities for process improvements to enhance quality and efficiency.

  • Stay Current with Industry Best Practices

Stay current with industry best practices and regulatory changes, incorporating them into the QA processes as appropriate.

Requirements
  • Bachelor's Degree in Life Sciences or a Related Field

Bachelor's degree in Life Sciences, Biotechnology, or a related field. Advanced degree preferred.

  • Minimum of 8-10 Years of Experience in Quality Assurance

Minimum of 8-10 years of experience in Quality Assurance within the biotech or pharmaceutical industry, with a focus on clinical-stage products.

  • Demonstrated Experience with GxP Compliance

Demonstrated experience with GxP compliance, particularly in GMP, GCP, and GLP environments.

  • Proven Track Record of Leading Regulatory Inspections

Proven track record of leading regulatory inspections and audits.

  • Hands-on Experience with QMS Implementation

Hands-on experience with QMS implementation and management in a small to mid-sized organization.

Why Meet?
  • Be Part of a Pioneering Biotech Company

Be part of a pioneering biotech company dedicated to developing cutting-edge therapies.

  • Work in a Collaborative and Fast-Paced Environment

Work in a collaborative and fast-paced environment with the opportunity to make a significant impact on the company's success.

  • Competitive Compensation Package

Competitive compensation package, including benefits and opportunities for professional growth.



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