Quality Systems Manager

GrayMatter Partners; Durham (NC); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading company is seeking a Quality Systems Manager to enhance their Quality Management System (QMS) in a remote role with extensive travel. The ideal candidate will ensure compliance with FDA and industry standards while managing quality operations and audits. This position requires a strong background in project management and quality systems within the life sciences sector.

Qualifications

• 5 years of experience in the life science industry.
• 3 years of direct project management experience.
• Strong knowledge of FDA and cGMP regulations.

Responsibilities

• Develop best practices in quality systems to drive compliance.
• Manage Quality Services staff and ensure compliance.
• Conduct organizational quality compliance audits.

Skills

Project Management

Quality Systems

Regulatory Compliance

Education

Master’s Degree in Scientific Discipline

Bachelor’s Degree in Engineering or Life Sciences

Job description

3 days ago Be among the first 25 applicants

Direct message the job poster from GrayMatter Partners

GrayMatter Partners is seeking a Quality Systems Manager for our start up client.

Location: Remote with extensive travel to support facilities within client's processing centers located in multiple locations in the US, including North Carolina.

Job Summary: We seek a highly skilled and motivated Quality Systems Manager to join our team. The ideal candidate, in collaboration with the Vice President of Operations, will promote and implement quality assurance practices designed to maintain regulatory and accreditation compliance with FDA, OSHA, and contracted partner regulations and standards.The candidate will be responsible for enhancing our Quality Management System (QMS) to align with our growth objectives.

Competitive compensation package commensurate with direct industry experience.

Essential Job Functions, Duties and Responsibilities include:

• Use and develop best practices in quality systems to drive compliance and assess operational needs to accurately, effectively, timely and compliantly achieve quality goals, including, but not limited to: investigations, deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements, Adverse Event and Complaints documentation, and management, quality operations, etc.
• Assures compliance with all SOPs, cGTP, FDA, as well as all applicable company compliance guidelines, standards and objectives.
• Direct and manage Quality Services staff to ensure quality management systems are in place, monitored and are in accordance with industry standards and organizational policies and procedures.
• Responsible for Quality Services functional area training, including onboarding and continuous learning.
• Oversee and conduct organizational quality compliance audits, including chart audits, to ensure current processes and procedures are complaint with internal policy and procedures, regulations, and industry standards.
• Manages external audits/inspections/accreditation site visits. Manage audit findings to ensure compliance and complete the required follow-up.
• Participate in company’s outreach and industry presence at organizational meetings and conferences, focusing on presenting the mission, professional focus, and partnership building.
• Continually adhere to all company’s policies, standard operating procedures, and work instructions including employee handbook and guidelines.
• Other duties as assigned.

Required Education:Master’s Degree is preferred, however a Bachelor’s Degree, in a scientific discipline, preferably engineering or life sciences with relevant industry experience is acceptable.

Required Work Experience:

• A minimum of 5 years of experience in the life science industry with at least 3 year of direct project management experience.
• Demonstrated experience in building and managing Quality Systems.
• Strong working knowledge of FDA and cGMP and cGTP regulations and documentation practices.
• Strong project management, business management/development skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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